Supplementary Appendix

Supplement to: Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic acid and cardiovascular outcomes in statin-
intolerant patients. N Engl J Med 2023;388:1353-64. DOI: 10.1056/NEJMoa2215024

This appendix has been provided by the authors to give readers additional information about the work.
 1
Supplementary Appendix

Index Page 1

Trial Leadership and Investigators Pages 2-37

Author Affiliations Page 38
Expanded Baseline Characteristics Table (Table S1) Page 39-40
Effects of Trial Regimens on Tertiary Lipid Parameters (Table S2) Page 41-42
Detailed Description of Muscle Adverse Events (Table S3) Page 43
Summary of Investigator-Reported Rhabdomyolysis Cases (Table S4) Pages 44-45
Flow of Patients Through the Trial (Figure S1) Page 46
Additional Kaplan Meier Curves for Key Secondary Endpoints (Figure S2) Pages 47-49
Effects of Trial Regimens in Prespecified Subgroups (Figure S3) Pages 50-51
Inclusion and Exclusion Criteria Pages 52-56
Statin Intolerance Confirmation Form Page 57
Endpoint Definitions Pages 58-76
Representativeness of Study Participants Pages 77-78
References Page 79
 2
CLEAR Outcomes Trial Leadership

Cleveland Clinic Coordinating Center for Clinical Research (C5Research): Steven E. Nissen, MD
(Study Chairman), A. Michael Lincoff, MD (Co-Principal Investigator), Stephen J. Nicholls, MBBS,
PhD (Co-Principal Investigator) 1, Venu Menon, MD (Director, CEC), Denise Mason, BSN (Lead
Project Manager), Kathy Wolski, MPH (Lead Statistician), Danielle Brennan, MS (Statistician),
Craig Balog, BS (Statistical Programmer), Jackie McCluskey, RN (Project Manager), Deborah
Davey, RN (Project Manager), Mary Del Valle, BSN (CEC Project Manager).
1
Current affiliation: Victorian Heart Institute, Monash University, Melbourne, Australia.

Esperion Therapeutics (Sponsor Leadership): JoAnne Foody (Chief Medical Officer), Michael J.
Louie (Senior Vice President, Clinical Development and Pharmacovigilance), LeAnne Bloedon
(Executive Director, Clinical Development), Paula Robinson (Senior Director, Clinical
Development), Jeffrey C. Hanselman (Senior Director, Clinical Development), Maggie Horner
(Executive Director, Clinical Operations), Pragna Patel (Senior Director, Clinical Operations),
Stephanie Kelly (Senior Director, Clinical Operations), Karen Stark (Senior Director, Clinical
Operations), Chien-Feng Chen (Vice President, Biometrics), Na Li (Senior Director, Biostatistics),
Ben Hong (Senior Director, Clinical Data Management), Ying Xiang (Director, Programming),
Genis Rodriguez (Executive Director, Portfolio Strategy and Asset Management), Burke Byrne
(Director, Global Regulatory Affairs), Satish Nachaegari (Executive Director, Global Regulatory
Affairs), Elisa Forman (Associate Director, Drug Safety and Pharmacovigilance Operations).

Executive Committee: Steven E. Nissen, MD (Study Chairman), A. Michael Lincoff, MD (Co-

Principal Investigator), Stephen J. Nicholls, MBBS, PhD (Co-Principal Investigator), Harold E.
Bays, MD, Leslie Cho, MD, Diederick E. Grobbee, MD, PhD, John JP Kastelein, MD, PhD, Peter
Libby, MD, Patrick Moriarty, MD, Jorge Plutzky, MD, Kausik K Ray, MD, MPhil*, Paul Thompson,
MD, Michael J. Louie, MD, MPH, MSc (non-voting member).
*Prof Ray is supported by the Imperial NIHR Biomedical Research Centre

National Coordinator Steering Committee (includes members of the Executive Committee and
the following National Coordinators): Michael Aschermann (Czech Republic), Maciej Banach
(Poland), Elana Baranova (Russia), Andreas Birkenfeld (Germany), Vera Bittner (United States),
Dirk Blom (South Africa), Gabriela-Valentina Ciobotaru (Romania), Mauricio Cohen (United
States), Andrej Dzupina (Slovakia), Andres Erglis (Latvia), David Fortuin (United States), Shaun
Goodman (Canada), Assen Gouda (Bulgaria), Steven Haine (Belgium), J Wolter Jukema
(Netherlands), Meral Kickingly (Turkey), Matyas Keltai (Hungary), Aleksander Knezevic (Croatia),
Peep Laanmets (Estonia), Jose Luis Leiva-Pons (Mexico), Jose Lopez-Sendon (Spain), Alberto
Lorenzatti (Argentina), Darren McGuire (United States), Carlos Francisco Jaramillo Muñoz
(Columbia), Jose Carlos Nicolau (Brazil), Henrik Nielsen (Denmark), Alexander Parkhomenko
(Ukraine), Andres Schuster (Chile), Peter J. Psaltis (Australia), Raul D. Santos (Brazil), Manish
Saxena (United Kingdom), Gerit Schernthaner (Austria), Bipin Kumar Sethi (India), Rimvydas
Slapikas (Lithuania), Goran Stankovic (Serbia), Harvey White (New Zealand).
 3

Independent Data Monitoring Committee: W. Virgil Brown, MD (Chairman), David E. Cohen,

MD, Joseph C. Gardiner, PhD.

Clinical Endpoints Committee: Cardiologists: Venu Menon (Medical Director), Jonathan

Hansen, Richard Meredith, Matthew Summers, Kenneth Varian, Bo Xu, Jeffrey Hedley, Anirudh
Kumar, Bryan Wilner, Nabil Sabbak, Calvin Sheng, Travis Howard, Balint Laczay, Ben Alencherry,
Zachary Goff; Neurologists: Jitendra Sharma; Orthopedic Surgeons: Alan Davis, Peter Evans,
John Delahay, Jessica Churchill, Alexander Roth; Diabetes Reviewer (Registered Nurses): Mary
Del Valle, Kimberly Brown, Mary Jo Heckman, Linda Kerchenski, Patricia D’Angelo, Christine
Shaffer; Nurses: Mary Del Valle (Lead CEC Project Manager), Kimberly Brown.

IQVIA (CRO): Linda Murray (Project Director), Virginie Rossi (Project Lead), Roberto
Marchioli, MD (Senior Medical Director), Jose Ferrari, MD (Senior Medical Director), Olga
Livchak (Global clinical lead), Melissa Kilroy (Retention Clinical Lead), Gaonkar Tushar (Lead
Centralized Monitoring Manager), Heather Murphy (Lead Biostatistics ), Stacy
Woodard, PhD (Biostatistics Director), Anitha Panicker (Data Team Lead), Shalonda
Deloatch, RN, BSN (CEVA Manager).

Julius Clinical (CRO): Marcel Bootsma, Msc (Project Director), Anne Marie Bruinsma, Bsc (Lead
Senior Project Manager), Nienke van Schaik, MD (Associate Project Manager), Niki de Vink
(Manager Regulatory), Arek Wrebiak, PhD (Clinical Team Lead), Anastasia Kurokthina (Clinical
Team Lead), Ifeoma Okeke (Clinical Team Lead), Wendy van Scherpenzeel (Lead Clinical Trial
Assistant).

CLEAR Outcomes Site Investigators and Study Sites
Investigator
Argentina
Rodolfo Andres Ahuad Guerrero
Carlos Alejandro Alvarez
Andres Alvarisqueta
Horacio Alberto Avaca
Horacio Alberto Avaca
Jorge Federico Baldovino
Marcelo Raul Barrionuevo
Ines Bartolacci
Mario Alberto Berli
Julio Bono
Nadia Budassi
Alberto Caccavo
Pedro Calella
Nicoletta Cantale
Mariano Chahin
Josefina Chirife
Gabriela Cecilia Coloma
Hugo Colombo
Federico Corinaldesi
Claudio Cosman
Juan Pablo Costabel
Alberto Cristino
Jesus Abel Cuadrado
Alvaro Daniel Facta
Maria Jazmin Fernandez Moutin
Fredy Ferre Pacora
Gustavo Daniel Frechtel
Jose Osvaldo Fretes
Elizabeth Gelersztein
Gustavo Giunta
Vanina Mariela Gorosito
Sonia Hermida
Miguel Hominal
Adrian Hrabar
Ricardo Alfonso Leon de la Fuente
Marcos Raul Litvak Bruno
4
Institution
Corporacion Medica de Gral. San Martin S.A., San Martin
Hospital Italiano Regional del Sur, Bahia Blanca
Centro de Investigaciones Medicas Mar del Plata, Mar del Plata
Hospital Britanico de Buenos Aires, Ciudad Autonoma de Buenos
Aires
CENTRO RESPIRE, San Fernando - Provincia de Buenos Aires
Centro de Investigacion CIMRO, San Rafael
Sanatorio Mayo Privado SA, Cordoba
Inst. Privado de Inv. Clinicas de Cordoba, Cordoba
Hospital Dr. Jose Maria Cullen, Santa Fe
Sanatorio Allende, Córdoba
Hospital Interzonal General de Agudos Dr Jose Penna, Bahia Blanca
Clinica Coronel Suarez, Coronel Suarez
CIPADI, Godoy Cruz
Centro de Investigaciones Clinicas Instituto del Corazon, Cordoba
CIMeL CHAHIN CHAHIN S.A., Lanus
Mutual Portuaria 21 de Diciembre, San Lorenzo
Policlinica Red Omip S.A, Mar del Plata
Clinica Colombo, Cordoba
Inst de Inv Clinicas-Bahia Blanca, Bahia Blanca
Maimonides University, Ciudad Autonoma de Buenos Aires
Instituto Cardiovascular Buenos Aires, Ciudad Autonoma Buenos
Aires
CCBR - Buenos Aires - AR, Ciudad Autonoma Buenos Aires
Framingham Centro Medico, La Plata
Hospital Privado de Comunidad, Mar Del Plata
Sanatorio Plaza, Rosario
Centro Medico Colon, Cordoba
Hospital Sirio Libanes, Caba
Expertia S.A- Mautalen Salud e Investigación, Ciudad Autonoma
Buenos Aires
CEDIC Centro de Investigaciones Clinicas, Buenos Aires
Hospital Universitario Fundacion Favaloro, Ciudad Autonoma
Buenos Aires
Laboratorio de Hemostasia y Trombosis (LAHT S.R.L.), Rosario
Consultorio de Atencion al Diabetico, Moron
Centro de Investigaciones Clínicas del Litoral SRL, Santa Fe
Instituto de Investigaciones Clinicas de Quilmes S.R.L., Quilmes
Centro Cardiovascular Salta, Salta
Consultorio Dr. Litvak Bruno, Ciudad Autonoma de Buenos Aires

Alberto Lorenzatti
Matias Nicolas Lugo
Hugo Armando Luquez
Ignacio MacKinnon
Claudio Rodolfo Majul
Natacha Maldonado
Maria Virginia Mansilla
Juan Medrano Allende
Oscar Montana
Sebastian Nani
Lucrecia Nardone
Eduardo Roque Perna
Pablo Pollono
Aldo Daniel Prado
Matias Alberto Re
Lucas Rista
Angela Maria Romero Zarante
Sonia Sassone
Andrea Patricia Serrano
Horacio Sessa
Maximiliano Sicer
Maria Victoria Sobredo
Jose Soler
Alvaro Sosa Liprandi
Maria Rosa Ulla
Marisa Liliana Vico
Nestor Alejandro Vita
Cesar Javier Zaidman
Australia
Andrew Ajani
Joseph Amin
Philip Aylward
James Andrew Black
David Colquhoun
David Cross
Anthony Dart
Ferdinandus de Looze
Akash Dhawan
5
Instituto DAMIC Fundacion Rusculleda, Cordoba
Centro de Investigaciones Medicas Temperley (CIMeT), Temperley,
Partido de Lomas de Zamora
Centro Medico Luquez, San Vicente
Instituto de Investigaciones Clinicas, Mar del Plata
CEMEDIC - Centro de Especialidades Medicas, Capital Federal
Instituto Médico Catamarca, Rosario
AXISMED S.R.L.- Clínica Mayo, San Miguel de Tucuman
Clinica y Maternidad Suizo Argentina, Ciudad Autonoma Buenos
Aires
DIM clinica Privadad, Ramos Mejia
Clinica Olivos, Vicente Lopez
CEMAIC - Centro Medico Privado, Cordoba
Instituto de Cardiologia de Corrientes, Corrientes
IDYTAC S.A., La Plata
Investigaciones Clinicas Tucuman, Tucuman
Hospital Italiano de La Plata, La Plata
CEDyN, Rosario
Centro de Investigaciones Metabólicas, Ciudad Autonoma de Buenos
Aires
Private Clinical Research, CADe-ICA, Buenos Aires
Centro Modelo de Cardiologia, San Miguel de Tucuman
Instituto Medico Fundación Grupo Colaborativo Rosario
Investigación y Prevención Medica, Rosario
Instituto de Investigaciones Clinicas de Rosario, Rosario
Sala Mignaburu, Berazategui
Investigaciones médicas IMOBA S.R.L., Ciudad Autónoma de
Buenos Aires
Sanatorio Guemes, Buenos Aires
CIDIM-Centro Integral de Diagnóstico por Imágenes Marchegiani,
Córdoba
Instituto de Investigaciones Clinicas Zarate, Zarate
Fundación de Estudios Clinicos, Rosario
CIPREC, Ciudad Autonoma Buenos Aires
Mildura Cardiology, Mildura, Victoria
Genesis HeartCare-Berwick, Berwick, Victoria
Heart & Vascular Institute, Adelaide, South Australia
Royal Hobart Hospital, Hobart, Tasmania
Core Research Group, Milton, Queensland
Heart Care Partners Pty Ltd., Auchenflower, Queensland
The Alfred Hospital, Melbourne, Victoria
AusTrials Pty Ltd. Taringa, Taringa, Queensland
Pendlebury Research Pty Ltd T/A Novatrials, Kotara, New South
Wales
 6
David Di Fiore Bundaberg Cardiology (FSPH), Bundaberg, Queensland
Stephen Etheredge Illawarra Health and Medical Research Institute (IHMRI),
Wollongong, New South Wales
Christopher Gilfillan Box Hill Hospital, Box Hill, Victoria
Shirley J. Jansen Sir Charles Gairdner Hospital Heart Research Institute, Nedlands,
Western Australia
Christopher Judkins Mount Hospital, Perth, Western Australia
Karam Kostner Dr Heart Pty Ltd, Woolloongabba, Queensland
Sam Lehman Adelaide Medical Research, Ashford, South Australia
Claire Morbey The Aim Centre, Merewether, New South Wales
Jamie Morton Adelaide Cardiology, Adelaide, South Australia
David O'Neal St Vincent's Hospital Melbourne, Fitzroy, Victoria
Cardiovascular Trials Western Australia, Joondalup, Western
Peter Purnell
Australia
Christopher Raffel The Prince Charles Hospital, Chermside, Queensland
Pradyot Saklani Heartcare WA - Murdoch, Murdoch, Western Australia
Carl Schultz Royal Perth Hospital, Perth, Western Australia
Robert Scott University of the Sunshine Coast, Sippy Downs, Queensland
Anand Sharma Ballarat Health Services, Ballarat, Victoria
Michael Stokes Royal Adelaide Hospital, Adelaide, South Australia
David Sullivan Royal Prince Alfred Hospital, Camperdown, New South Wales
Gregory Szto Peninsula Heart Centre, Frankston, Victoria
Maged William Gosford Hospital, Gosford, New South Wales
James Wolstenholme Mingara Medical Centre, Tumbi Umbi, New South Wales
Austria
Martin Clodi KH der Barmherzigen Bruder Linz, Linz
Christoph Ebenbichler Medizinische Universitat Innsbruck, Innsbruck
Peter Fasching Wilhelminenspital der Stadt Wien, Wien
Ursula Hanusch Zentrum fur klinische Studien Dr. Hanusch GmbH, Wien
Bernhard Ludvik Krankenanstalt Rudolfstiftung Wien, Wien
Walter Speidl Medical University of Vienna, Vienna
Hermann Toplak Universitatsklinikum Graz, Graz
Belgium
Dirk Bresseleers ZNA Jan Palfijn, Merksem
Luc Capiau BVBA Dr. Luc Capiau, Wetteren
Stéphane Carlier CHU Ambroise Pare, Mons
Frank Cools A.Z. KLINA, Brasschaat
Luc De Wolf Private Practice Dr. Luc De Wolf, Tienen
Fabian Demeure CHU UCL Namur, Mont-Godinne, Yvoir
Steven Haine Universitair Ziekenhuis Antwerpen, Edegem
Geert Hollanders Private Practice Cardiology, De Pinte
Tom Sarens AZ Sint-Blasius, Dendermonde
Benjamin Scott ZNA Middelheim, Antwerpen
Harry Striekwold Heilig Hart Ziekenhuis, Mol
Rene Tavernier AZ Sint-Jan Brugge, Brugge

John Thoeng
Philippe van de Borne
Philippe Vanduynhoven
Guy Vereecken
Geert Vervoort
Mathias Vrolix
Bart Wollaert
Brazil
Jamil Abdalla Saad
Eduardo Abib Junior
Valeria Cristina Aguiar
Gustavo Akerman Augusto
Fernando Augusto Alves da Costa
Rodrigo Alves da Silva
Renato Jorge Alves
Marianna Andrade Dracoulakis
Juliana Ascenção de Souza
Luciano Backes
João Borges
Luis Henrique Canani
Otavio Celeste Mangili
Rodrigo Julio Cerci
Fábio José Concilio Fucci
Ricardo de Gasperi
Maristela de Oliveira Beck
Freddy Eliaschewitz
Gilson Feitosa
Joao Felicio
Tania Maria Ferraz
Fernando Figueira
Helius Carlos Finimundi
Aguinaldo Freitas Junior
Benito Garbelini Junior
Lenara Golbert
Fernando Gomes
Octavio Gonzaga Neto
Cesar Hayashida
Artur Haddad Herdy
Conrado Hoffmann Filho
7
AZ Turnhout - Campus Sint-Elisabeth, Turnhout
ULB Hopital Erasme, Bruxelles
Algemeen Stedelijk Ziekenhuis Campus Aalst, Aalst
Vereecken Guy, Halen
AZ Sint-Maarten, Mechelen
Z.O.L - Campus St. Jan, Genk
ZNA Stuivenberg, Antwerpen
Hospital Felício Rocho, Belo Horizonte
Scentryphar Clinical Research, Campinas
Leforte - Liberdade, São Paulo
CPQuali Pesquisa Clínica Ltda., São Paulo
Clínica Paulista de Doenças Cardiovasculares Ltda., Bela Vista
Eurolatino Pesquisas Médicas Ltda., Uberlândia
Irmandade da Santa Casa de Misericordia de São Paulo, São Paulo
Hospital da Bahia, Salvador
CECAP - Centro de Cardiologia Clínica, Brasília
Hospital Sao Vicente de Paulo, Passo Fundo
Clínica de Endocrinologia e Metabologia Ltda., Brasília
Centro de Pesquisas em Diabetes Ltda., Porto Alegre
Hospital Paraná, Maringá
Quanta Diagnostico e Terapia, Curitiba
IMC - Instituto de Moléstias Cardiovasculares Tatuí, Tatuí
Associação Dr. Bartholomeu Tacchini - Instituto Tacchini de
Pesquisa em Saúde, Bento Goncalves
Centro de Pesquisa Médica Santa Maria Ltda., Santa Maria
CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo
Hospital Santa Isabel - Santa Casa de Salvador, Salvador
HUJBB-UFPA - Hospital Universitário João de Barros Barreto -
Universidade Federal do Pará, Belém
IEPE - Instituto de Estudos e Pesquisas, Fortaleza
Instituto de Medicina Integral Prof. Fernando Figueira – IMIP, Boa
Vista - Recife
IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos -
Universidade de Caxias do Sul, Caxias do Sul
CARDIOINTERV Centro de Pesquisa S/S, Goiânia
Prevencor - Center for Cardiovascular Prevention and Treatment,
Marilia/SP
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto
Alegre
CEDOES - Diagnóstico e Pesquisa, Vitória
CECIP - Centro de Estudos Clínicos do Interior Paulista, Jaú
Centro de Pesquisa do Hospital Santa Cruz, São Paulo
Instituto de Cardiologia de Santa Catarina, Sao Jose
Hospital Regional Hans Dieter Schmidt, Joinville

Carlos Isaia Filho
Adrian Paulo Morales Kormann
Silmara Alparecida Leite
Lilia Maia
Renan Montenegro Junior
Joao Batista Moraes Junior
Marco Antonio Mota Gomes
Bruno Ramos Nascimento
Carlos Vieira Nascimento
Fernando Neuenschwander
Milena Novaes Cardoso Curiati
Rafael Amorim Belo Nunes
Mayler Olombrada Nunes de Santos
Carlos Eduardo Ornelas
Cristiano Pederneiras Jaeger
Oscar Pereira Dutra
Marcio Antonio Pereira
Pedro Pimentel Filho
Eduardo Ramacciotti
Gilmar Reis
Jose Augusto Ribas Fortes
Marcelo Rodrigues Bacci
Alexandre Rodrigues
Paulo Roberto Ferreira Rossi
Luis Augusto Saliba
Maria Sanali Moura de Oliveira
Paiva
Wladmir Faustino Saporito
Jose Francisco Kerr Saraiva
Jaqueline Scholz
Pedro Gabriel Silva
Luis Augusto Tavares Russo
Henrique Tria Bianco
Alexandre Vargas Schwarzbold
Eduardo Vasconcellos
8
Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.
Carlos Isaia Filho Ltda, Porto Alegre
MK Blumenau Pesquisa Clínica, Blumenau
Cline Research Center (Leite PS Consultoria Medica LTDA),
Curitiba
Fundação Faculdade Regional de Medicina de São José do Rio Preto,
São José do Rio Preto
ICE-HUWC - Instituto Cearense de Endocrinologia do Hospital
Universitário Walter Cantídio, Fortaleza
Hospital Agamenon Magalhães, Recife
Centro de Pesquisas Clínicas Cesmac/Hospital do Coração de
Alagoas, Maceió
Hospital Universitario Sao Jose, Belo Horizonte
Instituto de Cardiologia do Distrito Federal, Brasilia
Hospital Vera Cruz - NUPEC - Nucleo de Pesquisa Clinica, Belo
Horizonte
Hospital Santa Marcelina, São Paulo
Hospital Alemão Oswaldo Cruz, Bela Vista
INGOH, GOIANIA
Centro de Pesquisa do Hospital Mater Dei, Belo Horizonte
Hospital Mãe de Deus, Porto Alegre
Instituto de Cardiologia do Rio Grande do Sul/ Fundação
Universitária de Cardiologia, Porto Alegre
ISPEM - Instituto São José dos Campos em Pesquisas Médicas, São
José dos Campos
Grupo Hospitalar Conceicao, Porto Alegre
HMCG - Hospital e Maternidade Dr. Christovao da Gama, Santo
André
CARDRESEARCH - Cardiologia Assistencial, Belo Horizonte
Pontifícia Universidade Catolica do Parana - PUCPR Epicenter,
Curitiba
Praxis Pesquisa Médica, Santo André
ICM - Instituto do Coração de Marília, Marília
Nucleo de Pesquisa Clinica, Curitiba
Dr. Consulta, São Paulo
Eurolatino Natal Pesquisas Médicas Ltda, Natal
Pesquisare Saúde S/S Ltda, Santo André
IPCC - Instituto de Pesquisa Clínica de Campinas, Campinas
Instituto Scholz de Pesquisa Clínica, São Paulo
Total Care - Unidade Jardins, São Paulo
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda., Rio de
Janeiro
Instituto Conceive, Paraíso, São Paulo
Hospital Universitário de Santa Maria /UFSM/EBSERH, Santa Maria
CCBR - Brasília, Brasília
 9
Maria Helena Vidotti Loema Instituto de Pesquisa Clinica e Consultores Ltda, Campinas
Bulgaria
Haralambi Benov MDHAT 'Dr. Stefan Cherkezov', AD, Veliko Tarnovo
Bojidar Dimov Fifth MHAT - Sofia EAD, Sofia
Tzvetan Dragoychev Medical Center Kalimat, Sofia
Yana Gavrailova Medical Center - Prolet Ltd, Ruse
Evgeni Georgiev Medical Center Diamedical - 2013' OOD, Dimitrovgrad
Yanka Gineva SNX, Stara Zagora
Mariana Gospodinova DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD, Sofia
Nina Gotcheva MHAT - "National Heart Hospital", EAD, Sofia
Assen Goudev UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia
Daniela Guenova Diagnostic Consultative Center II - Sofia OOD, Sofia
Valentin Hristov SHATC Pleven EAD, Pleven
Nikolay Iliev MHAT "Sv. Pantaleymon - Pleven", OOD, Pleven
Ivaylo Ivanov SNX, Sofia
Kostadin Kichukov SHATC "Sv. Georgi" - Pernik, OOD, Pernik
Georgi Levterov UMHAT "Kaspela", EOOD, Plovdiv
Viktor Margaritov MHAT "Yuliya Vrevska - Byala", EOOD, Byala
Lenko Mihov MHAT "Trakia", EOOD, Stara Zagora
Valentina Mincheva NMTH "Tsar Boris III", Sofia
Fedya Nikolov UMHAT "Sv. Georgi", EAD, Plovdiv
Galina Pencheva Fourth MHAT - Sofia EAD, Sofia
Nikolay Penkov SHATC - Varna, EOOD, Varna
Ivo Petrov Acibadem City Clinic University Hospital EOOD, Sofia
Dimitar Popov MHAT "Higia", AD - Pazardzhik, Pazardzhik
Dimitar Raev UMHAT 'Sveta Anna Sofia' AD, Sofia
Konstantin Ramshev Military Medical Academy - MHAT, Sofia
Nikolay Runev UMHAT "Alexandrovska" EAD, Sofia
Rabhad Shabani DCC "Alexandrovska", EOOD, Sofia
Ognyan Sherbanov MC Rusemed ltd., Ruse
Darko Simonov Diagnostic-Consultative Center I - Sliven, EOOD, Sliven
Yovka Stoycheva MHAT "Dr. Ivan Seliminski", AD, Sliven
Juliya Stoykova Military Medical Academy - MHAT - Pleven, Pleven
Milen Tanev SNX, Varna
Iveta Tasheva MC Start - d-r Todor Dimitrov EOOD, Sofia
Margarita Temelkova MHAT - Blagoevgrad, AD, EOOD, Blagoevgrad
Georgi Todorov Diagnostic Consultation Center CONVEX EOOD, Sofia
Stanislav Tsenov MHAT "Lyulin", EAD, Sofia
Haralin Tumbev SHATC "Cardiolife", OOD, Varna
Maria Tzekova Medical Center Medconsult Pleven OOD, Pleven
Ivailo Vasilev MHAT-Haskovo, AD, Haskovo
Chavdar Velikov MHAT Southwest hospital OOD, Sandanski
Sashko Zhezhovski MHAT "Sv. Panteleymon", AD, Yambol
Peyo Zhivkov MHAT 'Puls' AD, Blagoevgrad
 10
Mariya Zhivkova Miteva UMHAT "Sv. Georgi", EAD, Plovdiv
Canada
Naresh Aggarwal Aggarwal & Associates, Brampton, Ontario
Yves Beaudry ViaCar Recherche Clinique Inc., Saint-Lambert, Quebec
Ethel Bellavance Diex Research Victoriaville Inc., Victoriaville, Quebec
Guy Chouinard Recherche Clinique Sigma Inc., Québec, Quebec
Christian Constance Clinique Santé Cardio MC, Montréal, Quebec
Danielle Dion Centre Hospitalier Beauce-Etchemin, St Georges-de-Beauce, Quebec
Anthony Dowell Dynamik Research, Inc, Pointe-Claire, Quebec
Peter Dzongowski Milestone Research, London, Ontario
Daniel Gaudet ECOGENE-21, Chicoutimi, Quebec
Anil Gupta Dr. Anil K. Gupta Medicine Professional Corporation, Toronto,
Ontario
Michael Hartleib Kawartha Cardiology Clinical Trials, Peterborough, Ontario
Michael Heffernan Oakville Cardiovascular Research LLP, Oakville, Ontario
Sam Henein SKDS Research Inc., Newmarket, Ontario
Gordon Hoag Discovery Clinical Services Ltd., Victoria, British Columbia
Dennis O'Keefe Commonwealth Medical Clinic, Mount Pearl, Newfoundland
Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud,
Jean-Pierre Lavoie
Longueuil, Quebec
John O'Mahony London Road Diagnostic Clinic and Medical Centre, Sarnia, Ontario
Amritanshu Shekhar Pandey Cambridge Cardiac Care Centre, Cambridge, Ontario
Yves Pesant Unite de Recherche Clinique du CISSS des Laurentides, St-Jerome,
Quebec
Paul Poirier Institut Universitaire de Cardiologie et de Pneumologie de Quebec,
Quebec
Daniel Savard CardioVasc HR, St. Jean sur Richelieu, Quebec
Dinkar Shukla Dr Dinkar Shukla Professional Medicine Corp, Sudbury, Ontario
Francois St-Maurice ViaCar Recherche Clinique INC, Brossard, Quebec
Jean-Claude Tardif Montreal Heart Institute d/b/a Institut de Cardiologie de Montréal,
Montréal, Quebec
Chile
Carlos Conejeros Sociedad Medica Cardiologica El Llano, Santiago
Marcelo Medina Fariña Centro de Estudios Clinicos Barros Luco, Santiago
Manuel Eduardo Rodriguez
Venegas Hospital Sotero del Rio, Santiago
Carla Costanza Saavedra Pacheco CCBR- Santiago, Santiago
Margarita Vejar SMOLAM, Santiago
Colombia
IPS Centro Cientifico-Asistencial Jose Luis Accini S.A.S,
Jose Luis Accini Mendoza
Barranquilla
Camilo Arana Londono Centro de Investigaciones Clinicas S.A.S, Cali
Alirio Bastidas Healthy Medical Center, Zipaquira
Juan Fernando Carvajal Estupiñan Instituto del Corazon de Bucaramanga, Bucaramanga
Julian Coronel IPS Centro Medico Julian Coronel SAS, Cali
 11
Henry Jose Garcia Lozada Fundación Centro de Investigaciones Biomédicas Riescard, Espinal
Luis Hernando Garcia Ortiz Fundacion Centro de Investigaciones Clinica Ips Cardiomet Pereira,
Pereira
Alexander Gonzalez Dorado MEDPLUS Medicina Prepagada Chico, Bogota
Instituto de Investigacion Endocrinologia y Prevencion Metabolica -
Eric Hernandez Triana
ENDOCARE, Bogota D.C.
Manuel John Lievano Triana CardioColombia S.A.S., Bogota D.C.
Dora Ines Molina de Salazar Asociacion IPS Medicos Internistas de Caldas, Manizales
Sandra Mora Thiriez Fundacion Centro de Investigacion Clinica CIC, Medellín
Franklin Roberto Quiroz Diaz Fundación de Investigaciones Medicas San Gil - IPS, San Gil
Aristides Sotomayor Herazo Clínica Cardiovascular Santa Lucia, Cartagena
Fredy Alberto Trujillo Dada Corazon IPS S.A.S., Barranquilla
Carlos Alberto Velandia Carrillo IPS Caja de Compensación Familiar CAFAM, Bogotá
Croatia
Marinko Bilusic Polyclinic Bonifarm, Zagreb
Silvija Canecki Varzic Clinical Hospital Centre Osijek, Osijek
Krunoslav Fuckar Special Hospital for medical rehabilitation, Krapinske Toplice
Domagoj Futivic General Hospital Zabok, Zabok
Ivan Gornik Clinical Hospital Centre Zagreb, Zagreb
Sandra Jaksic Jurinjak Clinical Hospital Dubrava, Zagreb
Melita Jeric General Hospital Varazdin, Varazdin
Aleksandar Knezevic General Hospital Zadar, Zadar
Djivo Ljubicic Clinical Hospital Dubrava, Zagreb
Andreja Maric District Hospital Cakovec, Cakovec
Viktor Persic ThalassoTherapia Opatija, Opatija
Zeljko Popovic General Hospital Virovitica, Virovitica
Alen Ruzic Clinical Hospital Centre Rijeka, Rijeka
Kresimir Sutalo General Hospital "Dr.Tomislav Bardek", Koprivnica
Czech Republic
Vera Adamkova Institut klinicke a experimentalni mediciny, Praha 4
Vladimir Blaha Fakultni nemocnice Hradec Kralove, Hradec Kralove
Sylva Brtnikova Bioclinica Ostrava, Ostrava
Vladimir Cech Clinical Trials Services s.r.o, Uherske Hradiste
Jana Cepova Fakultni nemocnice v Motole, Praha 5
Ondrej Cermak Nemocnice Slany, Slany
Richard Ceska Vseobecna fakultni nemocnice v Praze, Praha 2
Vilem Danzig Vseobecna fakultni nemocnice v Praze, Praha 2
Lubomir Elbl Kardiologicka ordinace, Brno - Lesna
Richard Ferkl Kardiologicka ambulance MUDr. Ferkl s.r.o, Trutnov
Tomas Hala CCR Czech a.s., Pardubice
Michaela Honkova BENU Ceska republika a.s., Praha 1
Jan Hubac Kardiologicka ambulance, Chrudim
Igor Karen MUDr. Igor Karen s.r.o., Benatky nad Jizerou
Jiri Krupicka MEDICUS SERVICES s.r.o., Brandýs nad Labem
Jan Kvasnicka Kardiologicka ambulance, Praha 10
 12
Ondrej Ludka Lekarna Na Pekarske, Brno
Jiri Matuska CTC Hodonin s.r.o., Hodonin
Roman Miklik Vojenska nemocnice Brno, Brno
Karel Peterka Nemocnice Havlickuv Brod, p.o., Havlickuv Brod
Marian Pirchala SNX, Havirov
Jana Pisova Kardio-Pisova, s.r.o., Hradec Kralove
Robert Prosecky Nemocnice Milosrdnych bratri, Brno
Jiri Pumprla PreventaMed, s.r.o., Olomouc
Lea Raclavska Medicentrum Beroun, spol. s.r.o., Beroun
Petr Reichert Lekarna centrum, Teplice
Iva Skarpova Lekarna WPK / SNX, Praha
Jiri Skopek Thomayerova nemocnice, Praha 4-Krc
Josef Slaby Oblastni nemocnice Kolin, a.s., Kolin
Vladimir Soska Fakultni nemocnice u sv. Anny v Brne, Brno
Jan Vaclavik Kardio Vaclavik s.r.o., Prerov
Alica Vesela EDUMED s.r.o., Nachod
Jiri Vesely Edumed s.r.o, Broumov
Nemocnice ve Frydku-Mistku, prispevkova organizace, Frydek-
Kamil Zeman
Mistek
Eva Zidkova Corintez, Prague
Denmark
Gunnar Gislason Gentofte Hospital, Hellerup
Henrik Jensen Aarhus Univer. Hospital, Aarhus N
Jørgen Jeppesen Glostrup Hospital, Glostrup
Annette Justesen CCBR, Vejle
Morten Lindhardt Holbaek Sygehus, Holbæk
Dorthe Møller Viborg Sygehus, Viborg
Soren Nielsen CCBR, Ålborg
Peter Søgaard Aalborg University Hospital, Ålborg
Elgina Thomsen CCBR - Ballerup, Ballerup
Kristian Thomsen Sydvestjyds Sygehus Esbjerg, Esbjerg
Estonia
Arvo Rosenthal Dr. Arvo Rosenthal LLC, Tallinn
Germany
Ayham Al-Zoebi Kardiologische Praxis, Wermsdorf
Karl-Friedrich Appel Studienzentrum Dr. Appel, Kassel
Katrin Arelin SNX, Leipzig
Christoph Axthelm Cardiologicum Dresden und Pirna, Dresden
Juergen Berger-Roscher Praxis Dr. med. K.-H. Krause, Goch
Martin Bergmann Cardiologicum Hamburg, Hamburg
Jorg Berrouschot Klinikum Altenburger Land GmbH, Altenburg
Andreas Birkenfeld Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden
Hermann Braun Diabetespraxis Prenzlauer Allee, Berlin
Mareile Brunke (born Brakemeier) Klinische Forschung Hannover-Mitte GmbH, Hannover
Christel Contzen SNX, Frankfurt
 13
Karl-Michael Derwahl Institut fuer Klinische Forschung und Entwicklung (IKFE) Berlin
GmbH, Berlin
Markus Faghih Studienzentrum Bocholderstrasse, Essen
Sabine Genth-Zotz Katholisches Klinikum Mainz, Mainz
Siegfried Gerke Cardio Soest, Soest
Josef Grosskopf Grosskopf, Josef, Wallerfing
Dirk Hagemann Lehrpraxis der Ruhr-Universitat Bochum, Essen
Manfred Hartard Centrum fuer Diagnostik und Gesundheit, Munich
Christoph Hasslacher St. Josefskrankenhaus Heidelberg, Heidelberg
Frederik Johnson Innomed Dr. med. Naudts, Rodgau
Wolfgang Jungmair Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair, Bad
Homburg v.d. Höhe
Christoph Kadel Klinikum Frankfurt Hoechst GmbH, Frankfurt am Main
Gerd Kahrmann Evangelisches Krankenhaus, Witten
Uwe Kleinecke Zentrum fur Klinische Forschung, Koeln
Ulrich Laufs Universitaetsklinikum Leipzig AoeR, Leipzig
Stefan Leggewie Universitaetsklinikum Freiburg, Bad Krozingen
Manuela Licka Universitätsklinikum Heidelberg, Heidelberg
Joerg Luedemann Schwerpunktpraxis Dr. Luedemann fuer Diabetes Gefaess- und
Ernaehrungsmedizin, Falkensee
Rene Martz Clinical Research Hamburg GmbH, Hamburg
Candy Muenchhausen Klinische Forschung Berlin-Mitte GmbH, Berlin
Petra Ott Praxis Dr. med. Petra Ott, Dippoldiswalde
Ulrich Overhoff Zentrum fuer Praevention und Rehabilitation, Siegen
Pfützner Science & Health Institute Diabeteszentrum und Praxis,
Andreas Pfutzner
Mainz
Andrea Rinke SNX, Bochum
Axel Schaefer Medizentrum Essen Borbeck, Essen
Frank Schaper Gemeinschaftspraxis Schaper, Frank, Dresden
Isabelle Schenkenberger Klinische Forschung Berlin, Berlin
Zentrum fur klinische Forschung Dr. med. Irma Schoell, Bad
Irma Schoell
Homburg
Norbert Schulze Waltrup St.-Johannes-Hospital, Dortmund
Toralf Schwarz Internistische Facharztpraxis, Zwenkau
Andreas Schwittay Studienzentrum Dr. A. Schwittay, Boehlen
Horst Sievert CardioVaskuläres Centrum Frankfurt, Frankfurt/Main
Helena Sigal SIBAmed Studienzentrum GmbH & Co. KG, Leipzig
Gregor Simonis Facharztzentrum Dresden-Neustadt GBR, Dresden
Staedtisches Klinikum Bielefeld Gem. GmbH - Klinikum Mitte,
Christoph Stellbrink
Bielefeld
Uta Dorothea Stephan MVZ am Bahnhof Spandau, Berlin
Matthias Stratmann Kardiologische Praxis Gemeinschaftspraxis, Dortmund
Kerstin Sturm Emovis GmbH, Berlin
Heidrun Taeschner Gemeinschaftspraxis, Leipzig
Jens Taggeselle Taggeselle, Jens, Markkleeberg
 14
Charlotte von Engelhardt Klinische Forschung Schwerin GmbH, Schwerin
Dirk Weber UHZ Klinische Forschung, Essen
Joachim Weimer Praxis Dr. Weimer, Reinfeld
Norbert Weiss Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden
Ulrich Wendisch Gemeinschaftspraxis für Innere Medizin und Diabetologie, Hamburg
Thomas Wetzel Gemeinschaftspraxis fuer Kardiologie, Dortmund
Hungary
Tivadar Banyai SNX, Gyula
Tamas Barany Clinexpert Kft., Budapest
Bela Benczur Tolna Megyei Balassa Janos Hospital, Ist Dept. of Internal Medicine
(Cardiology/Nephrology), Szekszard
Amalia Benedek Vita Verum Medical, Székesfehérvár
Daniel Bereczki Semmelweis Egyetem, Budapest
Katalin Bezzegh DRC Ltd, Balatonfured
Gyongyike Birtha SNX, Zalaegerszeg
Emil Bod Kardio-Bod Kft., Debrecen
Peter Danos Obudai Egeszsegugyi Centrum Kft., Budapest
Csaba Dezsi Petz Aladar Megyei Oktato Korhaz, Gyor
Mihaly Dudas Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula
Istvan Edes Edes Szivunk Egeszsegkozpont Kft., Hajduszoboszlo
Judit Hegedus IPR Hungary Kft., Miskolc
Nikosz Kanakaridisz UNO Medical Trials Kft., Budapest
Katalin Keltai Semmelweis Egyetem, Budapest
Robert Gabor Kiss Magyar Honvedseg Egeszsegugyi Kozpont, Budapest
Attila Konyi COROMed-SMO Kft., Pecs
Laszlo Konyves Lausmed Kft., Baja
Laszlo Koranyi DRC LLC Balatongyorok, Balatongyörök
Zsolt Koszegi SNX, Nyiregyhaza
Ferenc Lakatos Belgyogyaszati es Kardiologiai Maganrendelo, Bekescsaba
Andras Matoltsy Kanizsai Dorottya Korhaz, Nagykanizsa
Bela Merkely Semmelweis Egyetem, Budapest
Lajos Nagy Markusovszky Egyetemi Oktatókórház, Szombathely
Laszlo Nagy Csongrad Megyei Dr. Bugyi Istvan Korhaz, Szentes
Jozsef Nemes Debrecen AS, Debrecen
Ebrahim Noori Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar
Tunde Pandur Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo, Papa
Elod Papp Dombovari Szent Lukacs Korhaz, Dombovar
Andras Papp Szent Rokus Hospital, Budapest
Gyorgy Paragh Debreceni Egyetem, Debrecen
Ãron Patvaros Orosháza Szentetornya háziorvosi körzet - LONA MEDIC Kft.,
Orosháza-Szentetornya
Ferenc Poor Karolina Korhaz-Rendelointezet, Mosonmagyarovar
Csaba Salamon Clinfan Szolgaltato Kft., Szekszard
Judit Simon CSALADGYOGYASZ Szolgaltato es Oktato Bt., Budapest
 15
Szilvia Szente DRC Szentendre, Szentendre
Szabolcs Szepesvari Kiskunhalasi Semmelweis Korhaz, Kiskunhalas
Sandor Szigeti SzIGO 2000 Szolgaltato Bt., Szentes
Timea Tanczer MED-TIMA KFT., Budapest
Kálmán Törőcsik JUTRIX Egészségügyi Kft, Kecskemet
Sandor Vangel Belinus Bt., Debrecen
Szilard Vasas BORBANYA PRAXIS Kft., Nyiregyhaza
Viktor Vass SNX, Budapest
Andras Vertes Istvan Cardiology Outpatient Clinic, Budapest
Andras Vorobcsuk Da Vinci Maganklinika, Pecs
Zsolt Zilahi Medifarma-98 Kft., Nyiregyhaza
Szilard Zolyomi Studium Egeszseghaz Kft., Kalocsa
India
Atul Abhyankar Shri B. D. Mehta Mahavir Heart Institute, Surat, Gujarat
Sunil Agarwal Oyster & Pearl Hospital, Pune, Maharashtra
Sunita Aggarwal Loknayak Hospital, New Delhi, Delhi
Archana Aher Government Medical College and Hospital, Nagpur, Maharashtra
Jaspal Singh Arneja Arneja Heart Institute, Nagpur, Maharashtra
Raghavendra Belgaonkar Sushruta Multispecialty Hospital and Research Centre Pvt. Ltd.,
Hubli, Karnataka
Ajit Bhagwat Kamal Nayan Bajaj Hospital, Aurangabad, Maharashtra
Nirav Bhalani Rhythm Heart Institute A Unit of Synergy Lifecare Pvt. Ltd.,
Vadodara, Gujarat
Atul Deshpande Deenanath Mangeshkar Hospital, Pune, Maharashtra
Hasmukh Dobariya Apple Hospital, Surat, Gujarat
Government Medical College and Hospital, Aurangabad,
Vijay Gaikwad
Maharashtra
Jugal Gupta Eternal Heart Care Centre, Jaipur, Rajasthan
Sandeep Kumar Gupta KRM Hospital & Research Centre, Lucknow, Uttar Pradesh
Pankaj Harkut Swasthyam Hospital, Nagar, Maharashtra
Latchumanadhas Kalidoss Madras Medical Mission, Chennai, Tamilnadu
Upendra Kaul Batra Hospital And Research Centre, Delhi, Delhi
Mohammad Aziz Khan Crescent Hospital & Heart Centre, Nagpur, Maharashtra
Hemant Kokane B. J. Medical College and Sassoon General Hospital, Pune,
Maharashtra
Parshottam Koradia BAPS Pramukhswami Hospital, Surat, Gujarat
Veerappa Kothiwale K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research
Centre, Belgaum, Karnataka
Sanjay Kumar Fortis Escorts Hospital, Faridabad, Haryana
Nikhil Parikh S.R.Kalla Memorial Gastro & General Hospital, Jaipur, Rajasthan
Balamurugan Ramanathan Kovai Diabetes Speciality Centre, Coimbatore, Tamilnadu
Bipin Kumar Sethi Care Hospital, Hyderabad, Andhra Pradesh
Aravind Ramchandra Sosale Diacon Hospital, Bangalore, Karnataka
Latvia
Jevgenijs Bondins Clinic of GP A.Lasmanis "ALMA", Riga

Ruta Eglite
Andrejs Erglis
Lilita Mitrofanova
Lija Mora
Inese Petrova
Aldis Strelnieks
Irina Veze
Lithuania
Jolita Badariene
Leone Cepinskiene
Valdas Dobilas
Roma Kavaliauskiene
Alina Kucinskiene
Nora Kupstyte-Kristapone
Jurate Lasiene
Rimvydas Slapikas
Danute Strazdiene
Gediminas Urbonas
Lina Venceviciene
Mexico
Fernando Aguilera Almazan
Felix Barrera
Edmundo Alfredo Bayram Llamas
Baldemar Eliodoro Castro Montes
Jorge Chavez
Rolando Chavez Martinez
Matilde Damian Hernandez
Erasmo De La Peña
Nilda Espinola Zavaleta
Pedro Fajardo Campos
Luis Fernando Flota Cervera
Jose Alberto Galvan Magana
Cecilia Garcia Ballesteros
Ricardo Garcia Gonzalez
Antonio Emilio Gonzalez Font
Jose Gerardo Gonzalez Gonzalez
Victor Gonzalez Lopez
Carlos Alberto Guizar Sanchez
16
Dr. R. Eglite`s Private practice, Kuldiga
Pauls Stradins Clinical University Hospital, Riga
OLVI Medical Centre, Daugavpils
Dr. L. Mora Private Practice, Ogre
Inese Petrova General Practitioner Practice, Tukums
Riga East Clinical University Hospital, Riga
Health Centre 4, Riga
Vilnius University Hospital Santariskiu Clinic, Public Institution,
Vilnius
Kaunas Clinical Hospital, Public Institution, Kaunas
Klinikiniai sprendimai, JSC, Kaunas
Cardiology and Rehabilitation Clinic, JSC, Klaipeda
Inmedica, JSC, Kaunas
Siauliai Republican Hospital, Public Institution, Siauliai
Vita Longa, JSC, Kaunas
Hospital of Lithuanian University of Health Sciences Kaunas Clinics,
Kaunas
Klinikiniai sprendimai, JSC, Alytus
Saules Seimos Medicinos Centras, JSC, Kaunas
Vilnius University Hospital Santariskiu Clinics, Public Institution,
Vilnius
Scientia, Investigación Clínica S.C., Chihuahua
InspirePharma, Monterrey, Nuevo León
Fundación Cardiovascular de Aguascalientes A.C., Aguascalientes
Pharmacology and Clinical Research S.A. de C.V., Queretaro, Qro.
Inst Diab Y Riesgo CV S.A., Puerto Vallarta
Nucleo Victoria de Inv Med SC, Durango
CEMDEC, S.A. de C.V., Mexico
Bioné-IPHARMA, Monterrey
CENTRO DE INVESTIGACIÓN CLINICA GRAMEL SC, Mexico
City
Centro de Investigacion Cardiovascular y Metabolica, Tijuana
Sociedad de Cirugia Vascular Plastica Reconstructiva de Angiologia
y Cardiologia SCP, Merida
Centro Especializado en Diabetes Obesidad y Prevencion de
Enfermedades Cardiovasculares S.C., Mexico
Centro de Investigación Integral Medivest S.C, Chihuahua
Instituto Jalisciense de Metabolismo S.C., Guadalajara
Instituto de Investigaciónes aplicadas a la Neurociencia A.C,
Durango
Universidad Autonoma De Nuevo Leon (Unal), Monterrey
Centro Especializado de Investigacion Medica Gonza, Culiacan
Clinstile, S.A. de C.V., Ciudad de México

Carlos Hernandez Herrera
Eduardo Herrera
Marisol Herrera Marmolejo
Silvia Jimenez
Marisela Jimenez-Sanchez
Jose Luis Leiva Pons
Guillermo Antonio Llamas Esperón
Norma Alicia Martinez Trejo
Julio Molina
Leocadio Muñoz Beltrán
Luis Alejandro Nevarez Ruiz
Juan Carlos Nunez Fragoso
Patricia Leny Nuriulu Escobar
Victoria del Carmen Padilla Raos
Gabriel Arturo Ramos Lopez
Ciro Manuel Riojas Charles
Luis Gerardo Rodriguez Torres
Jose Luis Romero
Alberto Esteban Bazzoni Ruiz
Maria del Lucero Sanchez Segura
Leobardo Sauque Reyna
Carlos Alejandro Stobschinski De
Alba
Maria Teresa Tapia de la Paz
Margarita Torres-Tamayo
Paul Gabriel Vazquez Contreras
Rafael Violante
Luis Ramon Virgen Carrillo
Eduardo Zambrano
Alberto Zamora Muciño-Arroyo
Netherlands
Mazin AlHakim
N. Al-Windy
H. Beyerbacht
Marcel Bokern
Fleur Borger van der Burg
Frederik Broeyer
Manuel Castro Cabezas
Jonas De Jong
17
Instituto Cardiovascular de Monclova, S de RL de CV, Monclova
Bioné-DEBBIOM, Monterrey
Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.,
Guadalajara
CICEJ. Centro de Investigacion Clinica Endocrinologica de Jalisco
S.C, Guadalajara
Consultorio de Endocrinologia y Nutriologia, Mexico
Hospital Central Dr Ignacio Morones Prieto, San Luis Potosi
Hospital Cardiologica Aguascalientes, Aguascalientes
Clinicos Asociados BOCM S,C, Mexico
ALTHIAN - Bioné-ALTHIAN, Monterrey
Leocadio Gerardo Muñoz Beltran, CD. Juarez
Investigacion en Salud y Metabolismo S.C., Chihuahua
Lahoja. Asociacion para la Investigacion y la Farmacovigilancia,
Durango
Investigación Biomédica Aplicada de Hidalgo S.A. de C.V., Pachuca,
Hidalgo
Desarrollo Ético en Investigación Clínica S.C, Guadalajara
Consultorio Medico Privado, Guadalajara
Global Trial Research Center, Monterrey
Diabetes and Nutrition Center S.C., Aguascalientes
Boca Raton Clinical Research Global, Querétaro
Centro de Investigacion Alberto Bazzoni S.A. de C.V., Torreon
RM Pharma Specialists SA de CV, Mexico
Instituto de Diabetes, Obesidad y Nutrición, S.C., Cuernavaca
Centro de Investigacion Medica Integral S.C., Guadalajara
Centro Integral en Reumatología, S.A. de .C.V, Guadalajara
INC - Endocrinología, Mexico City
Centro de Estudios de Alta Especialidad de Sinaloa CEAES,
Mazatlan
Centro de Estudios de Investigacion Metabolicos y
Cardiovasculares SC, Tamaulipas
Virgen Cardiovascular Research SC, Guadalajara
Clinical Trials México & ProcliniQ México, Pachuca
Instituto Biomedico de Investigacion, Aguascalientes
EB FlevoResearch, Almere
Gelre ziekenhuis, locatie Zutphen, Zutphen
Röpke Zweers Ziekenhuis, Hardenberg
Waterlandziekenhuis, Purmerend, Purmerend
Medisch Centrum Leeuwarden, Leeuwarden
Ziekenhuis Amstelland, Amstelveen
Sint Fransiscus Gasthuis, Rotterdam
Onze Lieve Vrouwe Gasthuis, Locatie Oost, Amsterdam
 18
E.C. De Melker OLVG locatie West, Amsterdam
F. den Hartog Ziekenhuis Gelderse Vallei, Ede
Maurits Dirksen Noordwest Ziekenhuisgroep, Alkmaar
Reinhart Dorman Bravis Roosendaal, Roosendaal
Saloua El Messaoudi Radboudumc, Nijmegen
Antonius Gosselink Isala Klinieken, Weezenlanden, Zwolle
B.E. Groenemeijer Gelre Ziekenhuis Apeldoorn, Apeldoorn
Fesile Gurlek Basar Admiraal De Ruyter Ziekenhuis, Goes
Barnabas Hamer Hamer, Barnabas, Amersfoort
Johannes Hans Post Catharina Ziekenhuis Eindhoven, Eindhoven
Simone Hartong Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht
W. Hermans St. Elisabeth Ziekenhuis, Tilburg
Marcel Hovens Rijnstate, Arnhem
Pieter Kamphuisen Tergooiziekenhuizen, Hilversum, Hilversum
Adriaan Kooy Bethesda Diabetes Research Center, Hoogeveen
Abraham Kroon Maastricht University Medical Center, Maastricht
G.C.M. Linssen Ziekenhuisgroep Twente Almelo, Almelo
Vyna Mahabier Huisartsenpraktijk Mw. V.S. Mahabier, Den Haag
Radjesh Mangal Huisartsenpraktijk Mangal, Den Haag
Anthonius Oude Ophuis Canisius - Wilhelmina Ziekenhuis, Nijmegen
Valeria Paradies Maasstad Ziekenhuis, Zuider, Rotterdam
Rene Peters Tergooiziekenhuizen, Blaricum, Blaricum
Francisco Prins Elkerliek Ziekenhuis, Helmond, Helmond
S. Rasoul Zuyderland Medisch Centrum, Heerlen
T. Romer Alrijne Ziekenhuis, Leiderdorp
Eelko Ronner Reinier de Graaf Groep, Delft
Dirk Schellings Slingeland Ziekenhuis, Doetinchem
Roderick Scherptong Leids Universitair Medisch Centrum, Leiden
Erik Stroes Academisch Medisch Centrum, Amsterdam
H. Swart D&A research, Sneek
Roland Troquay VIECURI MEDISCH CENTRUM, Venlo
E. van Beek Ziekenhuis St. Jansdal, Harderwijk
Thomas van Bemmel Gelre ziekenhuizen, locatie Lukas, Apeldoorn
Paul van Bergen Vasculair Onderzoek Centrum, Hoorn
Marcel van de Ree Diakonessenhuis Utrecht, Utrecht
M. van de Wetering BovenIJ ziekenhuis, Amsterdam
Ivo van der Bilt HagaZiekenhuis, Leyweg, Den Haag
Marcus van der Linden Franciscus Vlietland, Schiedam
Coenraad van der Zwaan Ziekenhuis Rivierenland, Tiel
Maarten van Hessen Het Groene Hart Ziekenhuis, Gouda
Klaas van Houwelingen Medisch Spectrum Twente, Haaksbergerstraat, Enschede
Rudolf van Leendert Albert Schweitzer Ziekenhuis, Zwijndrecht, Zwijndrecht
JWB Van Soerland Qclinical BV, Rotterdam
Ralph Verkleij Dokters van Nederhoven, Zwijndrecht
 19
Frank Visseren UMC Utrecht, Utrecht
I.C.D. Westendorp Rode Kruis Ziekenhuis, Beverwijk
P. Westendorp Beatrix Ziekenhuis, Gorinchem
Ka Wai Wu Van Weel-Bethesda Ziekenhuis, Dirksland
Ton Zijtregtop Huisartsenpraktijk Zijtregtop, Rotterdam
Stijntje Zoet-Nugteren Ikazia Ziekenhuis, Rotterdam
New Zealand
Jocelyne Benatar Auckland City Hospital, Grafton
Monica Ford Southern Clinical Trials Beckenham, Christchurch
Fraser Hamilton Waikato Hospital, Hamilton
Scott Harding Wellington Hospital, Wellington
Colin Helm Clinical Horizons NZ, Tauranga
Craig King Southern Clinical Trials (Totara Clinical Research), Auckland
Barnaby Montgomery Optimal Clinical Trials, Auckland
James Pemberton Dunedin Public Hospital, Dunedin
Dean Quinn P3 Research Limited (Wellington), Wellington
Russell Scott Lipid and Diabetes Research Group, Christchurch
Davitt Sheahan Culloden research Ltd, Papamoa
Susan Smith Southern Clinical Trials Waitemata ltd, Auckland
Ian Ternouth Taranaki Base Hospital, New Plymouth
Andrew To North Shore Hospital, Auckland
Michael Williams Lakeland Clinical Trials, Rotorua
Miles Williams Hawkes Bay Hospital, Hastings
Calum Young P3 Research Limited (Tauranga), Tauranga
Poland
Maciej Banach Instytut Centrum Zdrowia Matki Polki, Lodz
Renata Bijata-Bronisz NZOZ Centrum Medyczne KERmed, Bydgoszcz
Pawel Bogdanski Centrum Zdrowia Metabolicznego Paweł Bogdański, Poznań
Leszek Bryniarski Leszek Bryniarski Specjalistyczna Praktyka Lekarska, Krakow
Agnieszka Ciesiolkiewicz-Wojcik SNX, Wrocław
Ewa Czernecka SNX, Warszawa
Boguslaw Derlaga Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny,
Tarnow
Donald Drozdz NZOZ Zdrowie s.c. Agnieszka i Donald Drożdż, Wroclaw
Malgorzata Duszynska SNX, Poznan
Robert Glowka SNX, Lublin
Jacek Gniot Puławskie Centrum Kardiologiczne, Pulawy
Malgorzata Jagielska-Plata SNX, Gdansk
Grzegorz Kania Clinmedica Research, Skierniewice
Artur Klecha CARDIM, Nowy Targ
Malgorzata Konieczynska Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow
Jerzy Kopaczewski Specjalistyczne Gabinety Lekarskie Medicor Plus, Włocławek
Ewa Krzyzagorska Praktyka Lekarska Ewa Krzyzagorska, Poznan
Marian Krzyzanowski NZOZ Przychodnia “Łomżyńska”, DAN-MED Sp. z o.o., Bydgoszcz
 20
Wlodzimierz Kus Indywidualna Specjalistyczna Praktyka Lekarska, Lodz
Katarzyna Landa Landa Specjalistyczne Gabinety Lekarskie, Krakow
Grazyna Laszewska NS ZOZ Osrodek Diabetologiczny Popula, Bialystok
Tomasz Lepich Indywidualna Praktyka Lekarska Roman Spyra, Katowice
Anna Lochocka Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne
“OMEGA” Sp. z o.o., Plock
Stanislaw Mazur Centrum Medyczne Medyk, Rzeszow
SZPITAL SPECJALISTYCZNY W BRZOZOWIE PODKARPACKI
Sabina Medrek OŚRODEK ONKOLOGICZNY IM.KS.B.MARKIEWICZA,
Brzozów
Pawel Miekus NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog., Sopot
Beata Mikłaszewicz & Dariusz Dąbrowski “CARDIAMED” s.j.,
Beata Miklaszewicz
Legnica
Miroslaw Necki Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne
ProMiMed sp z o.o., sp.k., Krakow
Marta Obremska Przychodnia Vistamed, Wrocław
Andrzej Ochala Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Ochała,
Katowice
Anna Ocicka-Kozakiewicz Niepubliczny Zaklad Opieki Zdrowotnej “Nasz Lekarz” Praktyka
Grupowa Lekarzy Rodzinnych z, Torun
Marcin Ogorek NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety
Lekarskie, Lodz
Marcin Ojrzanowski SNX, Lodz
Boguslaw Okopien NZOZ Terapia Optima, Katowice
Magdalena Olszanecka
Glinianowicz SNX, Katowice
Edyta Opalinska OPTIMAMED Specjalistyczne Gabinety Lekarskie, Lublin
Longin Paszkowski SNX, Lodz
pecjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o. o.,
Piotr Pelczar
Lodz
Wojciech Piesiewicz Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz
Grzegorz Piotrowski Apteka WWCOiT im. M. Kopernika, Lodz
Ewa Pisarczyk-Bogacka Dobrostan Michal Bogacki, Wroclaw
Mieszko Plucinski Twoja Przychodnia-Centrum Medyczne Nowa Sol, Nowa Sol
Barbara Podogrodzka MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.,
Grodzisk Mazowiecki
Krzysztof Przybycien Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin
Andrzej Przybylski EMED Centrum Usług Medycznych, Rzeszów
Justyna Rogalska SNX, Czestochowa
Piotr Rozpondek Krakowskie Centrum Medyczne Sp. z o. o., Kraków
Izabela Sein Anand SNX, Gdynia
Grzegorz Skonieczny Wojew.Szpital Zespolony, Torun
Janusz Spyra Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia
Specjalistyczna A. Wittek, H. Rudzki, Ruda Slaska
Andrzej Stankiewicz Medyczne Centrum Diabetologiczno-Endokrynologiczno-
Metaboliczne DIAB-ENDO-MET, Krakow

Wojciech Szydlowski
Katarzyna Wierzbicka
Jaroslaw Wojcik
Izabela Wojtkowska
Iwona Wozniak
Danuta Wronska
Maciej Żabówka
Maciej Zarebinski
Witold Zmuda
Romania
Laurentia Andrei
Rodica Ioana Avram
Gabriela-Roxana Badea
Diana-Hortensia Barbonta
Imre Benedek
Alina Bisoc
Romi Filip Bolohan
Mihaela-Magdalena Busegeanu
Adriana Cif
Nicoleta Cindea Nica
Gabriela-Valentina Ciobotaru
Raluca Mihaela Ciomag
Radu Ciudin
Ciprian Constantin
Iulian Copaci
Carmen Crisan
Luiza Despina Demian
Rodica Doros
Adriana Dumitrescu
Georgiana Enache
Gabriela Silvia Gheorghe
Constantin Militaru
Cristina Mistodie
Mihaela Mociran
Magdalena Morosanu
Carmen Muresan
Gabriela Negrisanu
21
CenterMed Lublin Sp zoo, Lublin
Bioclinica Warsaw, Warszawa
OsKardInwazyjnej, Nałęczów
SNX, Warszawa
KO-MED Centra Kliniczne Pulawy, Pulawy
PRO FAMILIA ALTERA SPÓŁKA Z OGRANICZONĄ
ODPOWIEDZIALNOŚCIĄ, Katowice
Centrum Szybkiej Diagnostyki Kardiologicznej "KARDIOMED"
Maciej Żabówka, Ewa Żabówka, Tarnów
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana
Pawla II, Grodzisk Mazowiecki
Medicome Sp. z o.o., Oswiecim
Centrul Medical de Diagnostic si Tratament Ambulator Neomed
SRL, Brasov
Spitalul Judetean de Urgenta Deva (Deva County Emergency
Hospital), Deva
Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu", Balotesti
S.C Diana Barbonta S.R.L, Alba Iulia
Cardio Med SRL, Targu Mures, Targu Mures
Spitalul Clinic Judetean de Urgenta Brasov (County Clinical
Emergency Hospital Brasov), Brasov
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila,
Bucuresti
CMI Dr Busegeanu Mihaela Magdalena, Ploiesti
S.C Mediab S.R.L, Targu Mures
Centrul Medical Humanitas SRL, Bucuresti
S.C Medicalis S.R.L, Timisoara
S.C Policlinica CCBR S.R.L, Bucuresti
S.C. Bucharest International Medical Center S.R.L, Bucharest
Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila",
Bucharest
S.C Clinica Medicala Data Plus S.R.L, Bucuresti
S.C Mediab S.R.L, Targu Mures
S.C Anamed S.R.L, Oradea
I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu", Bucuresti
S.C. Centrul Medical “Sanatatea Ta” S.R.L., Bucharest
S.C. Ames Research Center S.R.L, Calarasi
Spitalul Clinic "Prof. Dr. Theodor Burghele", Bucuresti
Cardiomed, Craiova
Private Practice Dr. Mistodie Cristina Victoria, Galati
Spitalul Euromedica (Euromedica Hospital), Baia Mare
S.C Diamed Obesity S.R.L, Galati
Cardiomed Cluj-Napoca, Cluj-Napoca
Centrul Medical Dr. Negrisanu SRL - Diabetes, Timisoara
 22
Adriana Gabriela Onaca S.C Grandmed S.R.L, Oradea
Cristian Podoleanu Podoleanu G. Cristian-Gheorghe-Calin-Cardiology Medical Practice,
Targu Mures
Loredana Popa Spitalul Clinic Judetean de Urgenta Oradea, Oradea
Mircea-Ioachim Popescu Spitalul Clinic Judetean de Urgenta Oradea, Oradea
Monica Popescu S.C. HEALTH NET S.R.L, Bucuresti
Mihaela Simona Popoviciu "Medical Practice" SRL (Medical Practice Ltd.), Oradea
Camelia Pruna S.C Grandmed S.R.L, Oradea
Alina Roatis Spitalul Clinic Judetean de Urgenta Satu Mare (Satu Mare County
Clinical Emergency Hospital), Satu Mare
Doina Serban Spitalul Judetean de Urgenta Braila, Braila
Adrian Tase Spitalul Clinic Judetean de Urgenta Arges (Arges County Clinical
Emergency Hospital), Pitesti
Iulia Teodorescu Spitalul "Sf. Ioan" - Cardiology, Bucharest
Cristina Toarba S.C. Bella Praxis S.R.L, Pașcani
Mariana Tudoran Spitalul Clinic Judetean de Urgenta Pius Brinzeu, Timisoara
Daniela Zaharie S.C. Diametab Stud S.R.L., Zalau
Russian Federation
Natalia Afanasieva Nebbiolo LLC, Tomsk
Alina Agafina SPb SBIH "City Hospital # 40 of Kurortnyi region", Sestroretsk
Federal State Budgetary Educational Institution of Higher Education
"A.I. Yevdokimov Moscow State University of Medicine and
Evgeniya Akatova
Dentistry" of the Ministry of Healthcare of the Russian Federation,
Moscow
Sergey Aksentiev State Budgetary Healthcare Institution "Ryazan Regional Clinical
Hospital", Ryazan
Tatiana Anikina Limited Liability company "MSMC" Euromed, Omsk
Federal State Budgetary Educational Institution of Higher Education
“Academician I.P. Pavlov First St. Petersburg State Medical
Elena Baranova
University” of the Ministry of Healthcare of Russian Federation,
Saint-Petersburg
Olga Bokeriya FSBI "Scientific Center of Cardiovascular Surgery named after A.N.
Bakulev" of the MoH of the RF, Moscow
Svetlana Boldueva North-West State Medical University n.a. I.I. Mechnikov, Saint
Petersburg
Ekaterina Borisova Сlosed Joint Stock Company "Cardioclinica", Saint-Petersburg
Natalia Bulanova NS HCI "Central Clinical Hospital №6 open JSC "Russian
Railways", Moscow
Federal State Budgetary Institution "Advisory Diagnostic Center and
Natalia Burova Polyclinic" under the President's Affairs Department of the RF, Saint-
Petersburg
Danila Chizhov Saint-Petersburg State Institution of Healthcare "City Out-Patient
Clinic # 106", Saint Petersburg
Olga Chumakova SBIH of Moscow "City Clinical Hospital # 17", Moscow
Arkadiy Demko “Dep. Clin. Hosp. on Station Kemerovo of OAO “Russian
Railways”, Kemerovo

Dmitry Dronov
Vera Eltishcheva
Albert Sarvarovich Galyavich
Boris Goloshchekin
Ivan Gordeev
Irina Gubonina
Nadezhda Izmozherova
Svetlana Kalinina
Vasily Kashtalap
Larisa Khaisheva
Alexander Khokhlov
Gennadiy Khubulava
Vladimir Konstantinov
Viktor Kostenko
Mikhail Kotelnikov
Natalya Koziolova
Roman Kozlov
Oleg Kozyrev
Roman Libis
Konstantin Likhomanov
Nikita Lomakin
Yury Lukyanov
Svetlana Malchikova
Alexey Malikov
Alexander Malygin
Valentin Oleynikov
23
BIH of Omsk region "Clinical Medico-Sanitary Unit # 9", Omsk
Medical Centre "Alians", Kirovsk
Kazan State Medical University, Kazan
SPb SBIH "City Hospital # 15", St. Petersburg
SBIH of Moscow "City Clinical Hospital # 15 n.a. O.M. Filatov",
Moscow
LLC "RIAT SPb", Saint-Petersburg
Federal State Budgetary Educational Institution of Higher Education
"Ural State Medical University" of the Ministry of Healthcare of the
Russian Federation, Ekaterinburg
SBIH of Sverdlovsk region "Scientific and Practical Center of
Specilized Types of Medical Care", Ekaterinburg
FSBI “Scientific-research Institute for Complex Problems of
cardiovascular disease”, Kemerovo
MBHI "City Hospital of emergency health care of Rostov-on-Don",
Rostov-on-Don
SBEI HPE "Yaroslavl State Medical University" of the MoH of the
RF based on State Autonomous Institution of Healthcare of Yaroslavl
region "Clinical Hospital # 2", Yaroslavl
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the
MoD of the RF", Saint-Petersburg
Saint Petersburg SBIH "City Clinical Hospital # 23", Saint-
Petersburg
SPb SBIH "City Polyclinic # 109", Saint-Petersburg
FSFHI "Healthcare Unit of Ministry of Internal Affairs of Russian
Federation in Moscow", Moscow
SHI "Perm Territorial Hospital for War Veterans", Perm
Federal State Budgetary Educational Institution of Higher Education
"Smolensk State Medical University" of the Ministry of Healthcare of
the Russian Federation, Smolensk
SBEI HPE "Smolensk State Medical University" of the MoH of the
RF, Smolensk
Federal State Budgetary Educational Institution of Higher Education
“Orenburg State Medical University”, Orenburg
FSBI "Tomsk national research medical center of the Russian
Academy of Sciences", Tomsk
FSBI "Central Clinical Hospital with Polyclinic", Moscow
Pavlov First Saint Petersburg State Medical University, Saint-
Petersburg
FSBEI of HE "Kirov State Medical University" of MoH of Russian
Federation, Kirov
SPb SBIH "Nikolaevskaya Hospital", St. Petersburg
State Healthcare Institution of Yaroslavl Region "Clinical Hospital
#8", Yaroslavl
SBHI "Penza Regional Clinical Hospital n.a. N.N. Burdenko", Penza
 24
Irina Osipova SBEI HPE Altai State Medical University of MoH and SD, Barnaul.
Altayskiy Kray
SBIH of Novosibirsk region "City Clinical Hospital # 19",
Alla Ovsyannikova
Novosibirsk
Zhanna Paltsman LLC “Institute of Medical Examinations”, Saint-Petersburg
Aleksey Panov North-West Federal Medical Research Center n.a. V.A. Almazov,
Saint-Petersburg
Elena Pavlysh SPSBIH "City Polyclinic # 25 Nevskiy area", Saint-Petersburg
Sergey Pribylov Budgetary Medical Institution “Kursk Regional Clinical Hospital” of
Healthcare Committee of Kursk Region, Kursk
State Budgetary Institution of Heathcare of Moscow "City Clinical
Elena Reznik Hospital named after V.M. Buyanova of Department of Healthcare of
Moscow", Moscow
Maria Rossovskaya TSBIH “City Clinical Emergency Hospital n/a N.S. Karpovich”,
Krasnoyarsk
Ruslan Sardinov LLC «MedFort», Saint-Petersburg
Julia Shapovalova Non-State Institution of Healthcare, Chelyabinsk
Lubov Shpagina Municipal Institution of Healthcare «City Clinical Hospital #2»,
Novosibirsk
Victor Shunkov Non-state Healthcare Institution “Roadway Clinical Hospital of
OJSC Russian Railways”, Saint-Petersburg
Elena Shutemova Regional Budgetary Healthcare Institution "Cardiology Dispensary",
Ivanovo
Federal State Budgetary Institution of Higher Education “Saratov
Yury Shvarts State Medical University n.a. V.I. Razumovsky” of Ministry of
Healthcare of the Russian Federation, Saratov
Olga Smolenskaya MBI "CCCH #1 Oktyabrsk area", Ekaterinburg
German Sokurenko FSBI-The Nikiforov Russian Center of Emergency and Radiation
Medicine, Saint-Petersburg
Oleg Solovev Kirov Regional State Budgetary Healthcare "Kirov City Clinical
Hospital #1", Kirov
Ilya Staroverov SBIH of Yaroslavl region "Regional Clinical Hospital", Yaroslavl
Tatiana Supryadkina SBIH of Arkhangelsk region "First City Clinical hospital n.a. E. E.
Volosevich", Arkhangelsk
Federal State Budgetary Healthcare Institution “Central Clinical
Andrey Susekov
Hospital of Russian Academy of Sciences”, Moscow
Yulia Sycheva FSBEI HE I.P. Pavlov SPbSMU MOH Russia, Saint-Petersburg
Nikolay Tarasov FSHI “MSU of MoIA of RF of Kemerovo Region”, Kemerovo
Alexander Timofeev TSBIH "Territorial Clinical Hospital of Emergency Medical Care",
Barnaul
FSBI «V. A. Almazov Federal North-West Medical Research
Tatyana Treshkour Centre» of the Ministry of Health of the Russian Federation, Saint-
Petersburg
Galina Varvarina SBIH of N. Novgorod region"CityClinical Hospital #10 of
Kanavinskiy district of Nizhniy Novgorod", Nizhniy Novgorod
Elena Vishneva "Family Clinic", LLC, Ekaterinburg
 25
Alexander Vishnevsky SPB SBIH "Pokrovskaya City Hospital", Saint-Petersburg
Mikhail Voevoda FSBSI “Scientific Research Institute of Therapy and Preventive
Medicine”, Novosibirsk
Sergey Yakushin SBI of Ryazan region "Regional Clinical Cardiological Dispensary",
Ryazan
Konstantin Zrazhevskiy Saint Petersburg State Budgetary Institution of Healthcare "City
Hospital # 38 named after N.A. Semashko", Saint-Petersburg
Serbia
Svetlana Apostolovic Clinical Center Nis, Nis
Vera Celic Clinical Center " Dr Dragisa Misovic Dedinje", Belgrade
Miodrag Djordjevic Health Center Zajecar, Zajecar
Aleksandar Djukic Clinical Center Kragujevac, Kragujevac
Nikola Ivanovic General Hospital Sremska Mitrovica, Sremska Mitrovica
Jasmina Korica-Tresnjak Clinical Center Bezanijska kosa, Belgrade
Katarina Lalic Clinical Center of Serbia, Belgrade
Vladimir Miloradovic Clinical Center Kragujevac, Kragujevac
Milan Pavlovic Clinical Center Nis, Nis
Predrag Petrovic General Hospital Sveti Luka, Smederevo
Tatjana Potpara Clinical Center of Serbia, Belgrade
Violeta Randjelovic Krstic Military Medical Academy, Belgrade
Ivan Stankovic Clinical Center Zemun, Belgrade
Nadezda Trifunovic General Hospital Uzice, Uzice
Nenad Zec General Hospital Pancevo, Pancevo
Slovakia
Viera Ambrovicova CELL B s.r.o., Levice
Milan Banik Kardiologicka ambulancia MEDI M&M s.r.o., Moldava nad Bodvou
Olga Benusova BENROD s.r.o., Sturovo
Peter Blasko Kardiocentrum Nitra s.r.o., kardiologicka ambulancia, Nitra
Ingrid Buganova MEDIVASA s.r.o., Zilina
Peter Cicvara Thyreomedical s.r.o., Bardejov
Viera Donicova Human-Care s.r.o., Kosice
Katarina Dulkova Kardiovaskularne centrum, s.r.o., Bratislava
Tibor Duris Kardiologicka a interna ambulancia, Nove Zamky
Andrej Dzupina Alian s.r.o, MUDr. Andrej Dzupina, Bardejov
Jan Fedacko CARDIO D&R s.r.o., Kardiologicka ambulancia, Kosice
Peter Fulop Interna SK s.r.o., Svidnik
Jozef Gonsorcik Kardiologicka ambulancia, Kosice
Katarina Hatalova Cardioconsult s.r.o., Bratislava
Gabriel Kamensky Univerzitná nemocnica Bratislava, Bratislava 2 - Ružinov
Ivan Majercak Medical group Kosice sro, Kosice
Iveta Mancikova VITAL s.r.o., Levice
Emil Martinka Národný endokrinologický a diabetologický ústav n.o. v Ľubochn,
Lubochna
KARDIO-ONKOLOGIA s.r.o. Kardiologicka ambulancia., Dolny
Juraj Mazur
Kubin
 26
Karol Micko KARDIOMED, s.r.o., Lucenec
Jan Nociar Kardio1 s.r.o., Lucenec
Marek Pytliak Nemocnica arm. generala L. Svobodu Svidnik, a.s., Svidnik
Ferdinand Sasvary COR s.r.o., Sahy
Dana Solcova DIADAN, s.r.o. Kosice, Kosice
Dalibor Sosovec Tatratrial s.r.o. Diabetologicka ambulancia, Roznava
Jaroslava Strbova KARDIO-SANUS, spol. S.r.o., Bratislava
Livia Tomasova IN-DIA s.r.o., Lucenec
Jan Truban ENDIAMED, s.r.o., Dolny Kubin
Rudolf Uhliar Veria, s.r.o., Bratislava
Lubica Urgeova KARDIOMED NZ, s.r.o., Nove Zamky
Daniela Vinanska Medispol s.r.o. Interna a kardiologicka ambulancia, Presov
Tatiana Vykoukalova KARDIONITRA s.r.o. Ambulancia kardiologie, Nitra
South Africa
Lennard Baben SNX, Kempton Park, Gauteng
Dirk Blom Groote Schuur Hospital Lipid Laboratory, Cape Town, Western Cape
Johannes Breedt Emmed Research, Pretoria, Gauteng
Neville Chelin Londisizwe Research Centre, Durban, KwaZulu-Natal
Soritha Coetzer SNX, Cape Town, Western Cape
Clive Corbett Corbod Research, Cape Town, Western Cape
Madeleen de Villiers Dr M De Villiers, Pretoria, Gauteng
Johannes Engelbrecht Dr JM Engelbrecht Practice, Somerset West, Western Cape
Leon Fouche Limpopo Clinical Research Initiative, Thabazimbi, Limpopo
Nyda Fourie SNX, Bloemfontein, Free State
Mashra Gani Global Clinical Trials PE, Port Elizabeth, Eastern Cape
Adrian Horak Dr AR Horak Private Practice, Cape Town, Western Cape
Leonard Joubert Mzansi Ethical Research Centre, Middelburg, Mpumalanga
Cornelia Kapp Cardiology Clinical Research, Alberton, Gauteng
Landman Lombard Cape Town Medical Research Centre, Cape Town, Western Cape
Akbar Mahomed Dr AA Mahomed Medical Centre, Moloto, Mpumalanga
Larry Mey Johese Clinical Research, Centurion, Gauteng
Leya Motala MERC Cape Town, Cape Town, Western Cape
Helena Oosthuizen Oosthuizen, Helena, Pretoria, Gauteng
Soobramoney Pillay Dr SR Pillay Private Practice, Durban, KwaZulu-Natal
Elsje Potgieter SNX, Pretoria, Gauteng
Zelda Punt SNX, Port Elizabeth, Eastern Cape
Mary Seeber Seeber, M, Pretoria, Gauteng
Julien Trokis Langeberg Clinical Trials, Cape Town, Western Cape
Lelanie van Zyl The Arum Institute NPC, Pretoria, Gauteng
Louis van Zyl Clinical Projects Research SA (PTY) LTD, Worcester, Western Cape
Jean Vorster JOHESE Unitas, Centurion, Gauteng
Spain
Maria Del Carmen Cuesta Mayor Nuevas tecnologias en Diabetes y Endocrinologia, Sevilla
 27
Jose Ramon Gonzalez Juanatey Complejo Hospitalario Universitario de Santiago, Santiago de
Compostela, La Coruña
Rafael Hidalgo Urbano Hospital Universitario Virgen Macarena, Sevilla
Manuel Jimenez Navarro Hospital Clinico Universitario Virgen de la Victoria, Málaga
Manuel Martinez Selles Hospital General Universitario Gregorio Maranon, Madrid
Cesar Morcillo Serra Hospital SANITAS CIMA, Barcelona
Margarita Rivas Hospital Infanta Luisa, Sevilla
Violeta Rodriguez Rodriguez Hospital Virgen del Mar, Almeria
Juan Roldan Sanchez Institut Catala de Serveis Medics, Girona
Marcelo Sanmartin Fernandez Sanmartin Fernandez, Marcelo, Madrid
Alessandro Sionis Hospital de la Santa Creu i Sant Pau, Barcelona
Turkey
Ibrahim Basarici Akdeniz University Faculty of Medicine, Antalya
Yuksel Cavusoglu Osmangazi Uni Medical Faculty, Eskisehir
Ibrahim Gul Cumhuriyet Uni. Med. Fac., Sivas
Mehmet Kanadasi Cukurova University Medical Faculty, Adana
Cevat Kirma Kartal Kosuyolu Train. Res. Hospital, Istanbul
Ismail Turkay Ozcan Mersin University Medical Faculty, Mersin
Zerrin Yigit Istanbul University Cardiology Institute, Istanbul
Ukraine
Olga Barna Med Center of Eurolab LLC Policlinic Outpatient Dept
O.O.Bogomolets NMU, Kyiv
Vadym Berenfus NCE “Lviv city clinical hospital #4”, Lviv
Larysa Bezrodna SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv
Nataliia Boichuk SNX, Kyiv
Larysa Bula Limited Liability Company Clinic of Professor S. Khmil in Ternopil,
Ternopil
State Institution National Scientific Center Acad. M.D.Strazhesko
Sergii Cherniuk Institute of Cardiology of National Academy of Medical Sciences of
Ukraine, Unit of Non-Coronary Heart Diseases and Rheumatology,
Kyiv
Medical center of Subsidiary Company "Medical Research and
Oleksandra Donets Practice Center Medbud of the Private Joint Stock" Holding
Company "Kyivmiskbud", Kyiv
Sergiy Dotsenko CI Zaporizhzhia Regional Clinical Hospital of ZRC Dept of
Cardiology, Zaporizhzhia
Andriy Faynyk Communal Institution of Lviv Regional Council Lviv Regional
Clinical Treatment - Diagnostic Cardiological Center, Lviv
Dmytro Fedkov LLC MC Blagomed, Kyiv
Ivan Fushtey CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol &
endocrinology, Zaporizhzhia
Olga Gyrina LLC Treatment and Diagnostic Center Adonis Plus, Kyiv
Olha Horoshko CI of Kyiv RC Regional Clinical Hospital #2, Kyiv
Iryna Hovbakh Communal Institution of Healthcare, Kharkiv
Tetiana Ilashchuk City Clinic #3 Bukovinsky SMU, Chernivtsi
 28
Ganna Isayeva Government Institution L.T.Malaya Therapy National Institute of
NAMS of Ukraine, Unit of Cardiopulmonology, Kharkiv
Sergiy Karlov Communal Institution of Healthcare Kharkiv City Clinical Hospital
#8, Kharkiv
Oleksandr Karpenko Kyiv City Clinical Hospital #1, Kyiv
Mykhaylo Kolesnyk Educational and Research Medical Center "University Clinic" of
Zaporizhzhia State Medical University, Zaporizhzhia
Oleksii Korzh MC Doctor Alex Dept of General Practice-Family Medicine Kharkiv
MA of PGE, Kharkiv
Communal Institution Dnipro Clinical Association of Emergency
Olena Koval Medical Care of Dnipro City Council, Department of Cardiology for
Treatment of Patients with Myocardial Infarction #2, Dnipro
Oleksandr Kovalov SNX, Kyiv
Serhii Kozhukhov SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv
Igor Kraiz SMPI Central Clinical Hospital of Ukrzaliznytsia, Kharkiv
Olexandr Kuryata CI I.I. Mechnikov Dniprop.Reg.Cl.Hosp., Dept.of Pulmolon., SI
DSMA MOHU, Dnipro
Mykola Kushnir O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr RC,
Zhytomyr
Oles Kutnii Communal Institution Central City Hospital #2, City Center of
Ischemic Disease and Non-coronarogenic Heart Diseases, Zhytomyr
Olena Levchenko CI Odesa Regional Clinical Hospital, Odesa
Sergii Lozynskyi SNX, Vinnytsia
Yurii Lymar CNI Consultative and Diagnostic Center of Desnianskyi District of
Kyiv, Kyiv
MI RMC of Cardiovascular Diseases of Zaporizhzhia RC,
Yaroslav Malynovsky
Zaporizhzhia
Valentyn Maslovskyi Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1
Vinnytsia M.I.Pyrogov NMU, Vinnytsia
Olena Mitchenko SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv
Valeriy Molodtsov City Hospital #1, Mykolaiv
Olha Moroz Communal Institution of Healthcare Kharkiv City Clinical Hospital
#13, Department of Therapy, Kharkiv
Yuriy Mostovoy Private Small Enterprise Medical Center Pulse, Vinnytsia
Halyna Myshanych Kyiv Railway CH #2 of Branch Health Center of PJSC Ukrainian
Railway, Kyiv
Oksana Obertynska Medical Center LLC Health Clinic, Medical Clinical Investigational
Center, Unit of Cardiolody and Rheumatology, Vinnytsia
Nataliia Pertseva Communal institution City Clinical Hospital #9, Dnipro
Taras Petrovskyy "Limited Liability Company "Simedgrup", Ivano-Frankivsk
Oleksandr Prokhorov Communal Institution of Healthcare Kharkiv City Clinical Hospital
#27, Kharkiv
Dmytro Reshotko Medical Center of Limited Liability Company Medical Center
Concilium Medical, Kyiv
Leonid Rudenko Kyiv City Clinical Emergency Medical Care Hospital, Kyiv
 29
Inna Rudnytska Brovary Central Regional Hospital, Brovary
Iurii Rudyk GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine,
Kharkiv
Liudmyla Sapozhnychenko Limited Liability Company Medical Center Family Medicine Clinic,
Dnipro
Oxana Shershnyova Communal Institution Central Clinical Hospital #4 of Zavodskyi
district, Department of Cardiology, Zaporizhzhia
Sergii Shevchuk SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia
M.I.Pyrogov NMU MOHU, Vinnytsia
Yuriy Sirenko SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv
Vinnytsia M.I.Pyrogov Regional Clinical Hospital, Department of
Mykola Stanislavchuk Cardiology. Vinnytsia M.I.Pyrogov National Medical University,
Chair of Internal Medicine #1, Vinnytsia
Liudmyla Todoriuk Med Center 'Ok!Clinic+' of International Institute of Clinical Trials
LLC, Kyiv
Oleksandr Tokarenko CI City Hospital #1, Zaporizhzhia
Igor Vakaliuk Ivano-Frankivsk RCC Dispensary Dept of Infarction #2 SHEI Ivano-
Frankivsk NMU, Ivano-Frankivsk
Myroslava Vayda Transcarpathian Regional Clinical Cardiology Dispanser, Uzhgorod
Olga Verbovska Ivano-Frankivsk Central City Clinical Hospital, Department of
Cardiology, Ivano-Frankivsk
Nataliia Virstyuk Ivano-Frankivsk CCH Dept of Therapy #1 SHEI Ivano-Frankivsk
NMU, Ivano-Frankivsk
Lyudmyla Vynnychenko CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU, Sumy
Communal Institution Lutsk City Clinical Hospital Volyn Regional
Andriy Yagensky Center of Cardiovascular Pathology and Thrombolysis, Department
of Rehabilitation, Lutsk
Svitlana Zhurba Cherkasy Regional Cardiological Center, Department of Acute
Coronary Insufficiency and Rhythm Disturbance, Cherkasy
United Kingdom
Paul Ainsworth Sherbourne Medical Centre, Leamington Spa
Lawrence Barnes Rame Medical Limited, Torpoint
Samuel Lassa Ashgate Medical Practice, Chesterfield
Richard Burkimsher Mounts Bay Medical Ltd, Hayle
Michael Butler Waterloo Medical Centre, Blackpool
Rebecca Clark Layton Medical Centre, Blackpool
Ryan D'Costa Pinderfields General Hospital, Mid Yorkshire Hospitals NHS Trust,
Yorkshire
Karen Faulkner SNX, Birmingham
Jacob George Ninewells Hospital, Dundee
Lisa Gibbons Claremont Medical Practice, Exmouth
Anthony Gunstone The Staploe Medical Centre, Soham
Timothy Hall Knowle House Surgery, Crownhill, Plymouth
Shalini Iyengar SNX, Stockton on Tees
Shalini Iyengar SNX, Hexham
 30
Sudha Iyer Basildon University Hospital, Basildon
Ewart Jackson-Voyzey Axbridge and Wedmore Medical Practice, Axbridge
Nicholas Jones St Chad's Surgery, Somerset
Christina Kyriakidou SNX, Reading
Kelvin Lee United Lincolnshire Hospitals NHS Trust, Lincoln
Paula Marrett Fowey Medical Practice, Fowey
Terry McCormack Whitby Group Practice, Whitby
Imrozia Munsoor SNX, Bellshill
David Newby Royal Infirmary of Edinburgh, Edinburgh
Helen Nicholls SNX, Cardiff
Neil Paul Ashfields Primary Care Centre, Cheshire
Alastair Pell Monklands Hospital, Airdrie
Manish Saxena Barts Hospital, London
Sumeet Sharma St Peter's Hospital, Chertsey
Jolanta Sobolewska Northern Care Alliance NHS Group, Oldham
Alexander Trotman Beacon medical centre, Chaddlewood
Marianne Viljoen Synexus Lancashire Clinical Research Centre, Lancashire
Marianne Viljoen Synexus Merseyside Clinical Research Centre, Merseyside
Marianne Viljoen Synexus Manchester Clinical Research Centre, Greater Manchester
United States
Rafik Abadier Nature Coast Clinical Research, LLC, Inverness, Florida
Kenneth Adams Pentucket Medical Associates, Haverhill, Massachusetts
Michael Adams SNX, Murray, Utah
Saleem Akbar Cardiovascular Physicians Solution, Allen, Texas
Northeast Clinical Research of San Antonio, LLC, San Antonio,
Laura Akright
Texas
Mohsin Alhaddad Apex Cardiology/ Research Associates of Jackson, Jackson,
Tennessee
Mohammed Allaw SNX, Evansville, Indiana
Shravan Ambati Oralndo Heart & Vascular Center LLC, Orlando, Florida
Marshall Anderson Kernodle Clinic, Inc., Dept. of the Private Diagnostic Clinic, PLLC,
Burlington, North Carolina
Shamaila Aslam Northwest Houston Heart Center, Tomball, Texas
Karen Aspry The Miriam Hospital, Providence, Rhode Island
Nizar Assi Gateway Cardiology Research Center, St. Louis, Missouri
Mahmoud Atieh Pinehurst Medical Clinic, Sanford, North Carolina
Eric Auerbach Oklahoma Heart Institute, Tulsa, Oklahoma
Vivek Awasty Awasty Research Network, LLC, Marion, Ohio
Iftekhar Baig Nova Clinical Research, LLC, Bradenton, Florida
Tamas Balogh Clinical Trials of America-NC, LLC, Mt. Airy, North Carolina
Rancho Cucamonga Clinical Research, Rancho Cucamonga,
Steven Barag
California
Kim Barbel-Johnson Care Partners Clinical Research, LLC, Jacksonville, Florida
Research Institute of the Carolinas, PLC, Mooresville, North
Timothy Barker
Carolina
 31
Seth Baum Excel Medical Clinical Trials LLC., Boca Raton, Florida
Harold Bays L-MARC Research Center, Louisville, Kentucky
Matthew Beacom Beacom Family Health Connection, Fremont, Nebraska
Richard Beasley Health Concepts, Rapid City, South Dakota
Gary Bedel Prestige Clinical Research, Franklin, Ohio
Jennifer Bellucci-Jackson Clinical Investigation Specialists, Inc., Gurnee, Illinois
Barry Bertolet Cardiology Associates Research, LLC, Tupelo, Mississippi
Kenneth Bescak Verde Valley Medical Ctr, Cottonwood, Arizona
Cardiovascular Research of Northwest Indiana, LLC, Munster,
Ravi Bhagwat
Indiana
Zulfiquar Bhatti Columbus Regional Research Institute, Columbus, Georgia
Kenneth Blaze South Broward Research, LLC, Pembroke Pines, Florida
Thomas Blok Western Michigan University Homer Stryker M.D. School of
Medicine Center for Clinical Research, Kalamazoo, Michigan
Fernando Boccalandro Permian Research Foundation, Odessa, Texas
Paul Boffetti Foundation Medical Partners d/b/a Southern New Hampshire
Diabetes and Endocrinology, Nashua, New Hampshire
John Borders Synexus Clinical Research US, Inc., Lexington, Kentucky
David Brabham Pharma Tex Research, LLC, Amarillo, Texas
David Browder PMG Research of Rocky Mount, LLC, Rocky Mount, North Carolina
Christopher Brown Mobile Heart Specialists, PC, Mobile, Alabama
Tami Bruce Synexus Clinical Research US, Inc., Mesa, Arizona
Joseph Burchenal South Denver Cardiology Associates, PC, Littleton, Colorado
David Butuk Solaris Clinical Research, Meridian, Idaho
Thomas Buzbee CareTech Clinical Trials, LLC, Tyler, Texas
William Byars Tribe Clinical Research, Greenville, South Carolina
Cornell Calinescu SNX, Henderson, Nevada
Jose Cardona Indago Research & Health Center, Inc., Hialeah, Florida
Kenneth Carr Blue Coast Cardiology, Vista, California
Gildardo Ceballos Med-Olam Clinical Research, LLC, Sugar Land, Texas
Jeanne-Elyse Cedeno Family Clinical Trials, LLC., Pembroke Pines, Florida
Jose Cevallos Yepez Finlay Medical Research Corp, Greenacres, Florida
Miguel Chamah Qway Research LLC, Hialeah, Florida
Harish Chandna Victoria Heart & Vascular Center, Victoria, Texas
Deanna Cheung Long Beach Center for Clinical Research, Long Beach, California
Felix Chion-Fong Med-Care Research, Miami, Florida
Leslie Cho Cleveland Clinic Cardiology, Cleveland, Ohio
Leslie Cho Cleveland Clinic Fairview Hospital, Cleveland, Ohio
Leslie Cho Cleveland Clinic Beachwood Hospital, Beachwood, Ohio
Melissa Choi SNX, Richfield, Minnesota
Main Street Physician's Care - Waterway, Little River, South
Tom Christensen
Carolina
Kenneth Cohen New West Physicians, PC, Golden, Colorado
Harry Colfer McLaren Northern Michigan Hospital, Petoskey, Michigan
Lisa Connery Intend Research, Norman, Oklahoma
 32
Erin Cooksey Synexus Clinical Research US, Inc., Anderson, South Carolina
Brian Crenshaw LeBauer Cardiovascular Research Foundation, Greensboro, North
Carolina
Jairo Cruz Specialty Physicians of Illinois, Olympia Fields, Illinois
Nizar Daboul Advanced Medical Research, Maumee, Ohio
Charles Dahl Aspen Clinical Research, Orem, Utah
George Daniel Bethesda Hospital East, Boynton Beach, Florida
Giselle Debs-Perez Harmony Clinical Research, Inc., North Miami Beach, Florida
Jeffery DeGrauw SNX, Layton, Utah
Patrick Dennis DelRicht Research, New Orleans, Louisiana
Chrisette Dharma Southwest Family Medicine Associates, Dallas, Texas
James Diener Cadillac Clinical Research, LLC, Cadillac, Michigan
Ayotunde Dokun Lipid Research Clinic - University of Iowa, Iowa City, Iowa
Sean Donahoe Division of Cardiovascular Research at Peconic Bay Medical Center,
Riverhead, New York
Andrew Drabick Medication Management, LLC, Raleigh, North Carolina
Daniel Duprez University of Minnesota, Minneapolils, Minnesota
John Earl PMG Research of Hickory, LLC, Hickory, North Carolina
Cara East Soltero Cardiovascular Research Center, Dallas, Texas
Frank Eder Regional Clinical Research / United Medical Associates,
Binghamton, New York
William Ellison SNX, Greer, South Carolina
Brian Everhart Heritage Valley Medical Group, Inc., Beaver, Pennsylvania
Stephen Farkas DaVita Clinical Trials, LLC, Colorado Springs, Colorado
Atoussa Farough Cardinal Internal Medicine Associates, Woodbridge, Virginia
Lawrence Feld Horizon Clinical Research Associates, PLLC, Gilbert, Arizona
Jonathan Fialkow Cardiovascular Research Center of South Florida, Miami, Florida
Gregory Flippo Alabama Clinical Therapeutics, LLC, Birmingham, Alabama
Enrique Flores Georgia Heart Specialists, Covington, Georgia
Leslie Forgosh HealthEast Care System, St. Paul, Minnesota
Jean Foucauld Cardiology Partners Clinical Research Institute, LLC, Wellington,
Florida
William French Harbor UCLA Medical Center, Torrance, California
Keith Friedman Johns Hopkins University, Columbia, Maryland
Nashwa Gabra Burke Internal Medicine & Research, Burke, Virginia
Peter Gagianas Primary Care Research South, Inc, McMurray, Pennsylvania
Oscar Galvez Prestige Clinical Research Center, Inc, Coral Gables, Florida
Jagadeesh Ganji Medication Management, LLC, Greensboro, North Carolina
Raktim Ghosh MedStar Medical Group Cardiology at Union Memorial, Baltimore,
Maryland
Syed Gilani Clearwater Cardiovascular Consultants, Largo, Florida
Eve Gillespie Glacier View Research Institute-Cardiology, Kalispell, Montana
Richard Gilmore Imperial Health, LLP, Lake Charles, Louisiana
Lawrence Gimple University of Virginia Health Systems, Charlottesville, Virginia
Narendra Godbole Summit Medical Group Arizona, LLC - Glendale, Glendale, Arizona
 33
Nicholas Goetsch Northeast Iowa Medical Education Foundation, Waterloo, Iowa
Marcy Goisse Frontier Clinical Research, Smithfield, Pennsylvania
Jose Gomez-Cortes Elite Clinical Research, Miami, Florida
James Gray Middle Tennessee Clinical Research, Fayetteville, Tennessee
James Greenwald Medex Healthcare Research, Inc, New York, New York
Colby Grossman Palmetto Clinical Research, Summerville, South Carolina
Maleah Grover DaVita Clinical Trials, LLC, Long Beach, California
Tariq Haddad Virginia Heart, Falls Church, Virginia
Stephen Halpern SNX, Santa Rosa, California
Ekram Hanna SNX, Bridgeton, New Jersey
Rocio Harbison Juno Research, LLC, Houston, Texas
Terence Hart Terence T. Hart, MD, Tuscumbia, Alabama
Paul Hartley Preferred Primary Care Physicians, Uniontown, Pennsylvania
Steven Hearne Delmarva Heart Research Foundation, Inc., Salisbury, Maryland
Oscar Hernandez NextPhase Clinical Trials Inc, Miami, Florida
Tatiana Hernandez Bayside Clinical Research LLC, Trinity, Florida
Carlos Herrera Heights Doctors Clinic, Houston, Texas
Darrell Herrington Benchmark Research San Angelo, San Angelo, Texas
David Herrington Wake Forest University, Winston-Salem, North Carolina
Mitzie Hewitt Northern Pines Health Center, Buckley, Michigan
Daniel Humiston Utah Cardiology, Clinton, Utah
Matthew Hummel Synexus Clinical Research US, Inc., Fountain Hills, Arizona
John Hunter Santa Rosa Cardiology Medical Group, Inc., Santa Rosa, California
Melissa Ianitelli McLaren-Macomb Research, Mt. Clemens, Michigan
Faizan Iftikhar Complete Heart Care PA, McKinney, Texas
Carlos Ince Maryland Cardiovascular Specialists, Baltimore, Maryland
Steven Isserman Clinical Trials of America-NC, LLC, Hickory, North Carolina
Mahendra Jain Houston Methodist Research Institute - CCAT Pearland, Pearland,
Texas
Stephan Jannach Spectrum Medical, Inc., Danville, Virginia
William Jennings SNX, San Antonio, Texas
Preetham Jetty Community Clinical Research Center, Anderson, Indiana
Nicholas Kalayeh Next Phase Research Alliance, Las Vegas, Nevada
Hudson Valley Cardiovascular Practice, PC, Poughkeepsie, New
Louis Kantaros
York
Richard Kastelic Richard M Kastelic, MD and Associates / Berkley Hills Clinicals,
Johnstown, Pennsylvania
Samer Kazziha Crittenton Hospital Medical Center, Sterling Heights, Michigan
Vipin Khetarpal Michigan Cardiovascular Institute, Saginaw, Michigan
Sandeep Khurana Healthy Heart Cardiology, Grand Rapids, Michigan
Murray Kimmel Optimal Research, LLC, Melbourne, Florida
William Kirby Simon-Williamson Clinic, Birmingham, Alabama
James Kopp SNX, Anderson, South Carolina
Michael Koren Jacksonville Center for Clinical Research, Jacksonville, Florida
Denes Korpas Nebraska Heart Institute, Lincoln, Nebraska
 34
Hector Labrada A+ Research Inc., Miami, Florida
Ajay Labroo Advanced Cardiovascular Consultants, Rock Island, Illinois
Audrey Lacour Juno Research, LLC, Houston, Texas
John Larry Ohio State University, Columbus, Ohio
Mary Lawrence Carteret Medical Group, Morehead City, North Carolina
Samuel Lederman Altus Research, Inc., Lake Worth, Florida
Keung Lee Randolph Medical Associates, Asheboro, North Carolina
Richard Leggett Crossroads Clinical Research, LLC, Victoria, Texas
Robert Lending Synexus Clinical Research US, Inc., Tucson, Arizona
Thomas Lenzmeier Synexus Clinical Research US, Inc., Glendale, Arizona
Westside Medical Associates of Los Angeles, Beverly Hills,
Norman Lepor
California
Peter Levins SNX, Phoenix, Arizona
David Lewis Meriter Medical Group, Inc., Madison, Wisconsin
Michael Lillestol Lillestol Research LLC, Fargo, North Dakota
Hugo Llanes Clinical Research Associates of South Florida, Miami, Florida
Sara Llerena Columbus Clinical Services, LLC, Miami, Florida
Mario Lopez Charlotte Heart & Vascular Institute, PA, Port Charlotte, Florida
Eric Lorraine Regional Clinical Research, Inc, Endwell, New York
James Lovell The Iowa Clinic, PC, West Des Moines, Iowa
Kathryn Lucas Diabetes and Endocrinology Consultants, Morehead City, North
Carolina
Charles Lunn SNX, Oklahoma City, Oklahoma
Sharan Mahal Advanced Heart Care, LLC, Bridgewater, New Jersey
Naveed Mahfooz A1 Clinical Research, Caro, Michigan
Sashi Makam Mid Hudson Medical Research, PLLC, New Windsor, New York
Isam Marar West Broadway Clinic, Council Bluffs, Iowa
Cindy Martinez Project 4 Research, Miami, Florida
Joaquin Martinez-Arraras Amarillo Heart Clinical Research Institute, Inc., Amarillo, Texas
Brian McCormick Hampton Family Practice, PLLC, Hampton, Virginia
Tegan McCormick Christie Clinic, LLC, Champaign, Illinois
Kevin McCullum York Hospital, York, Pennsylvania
Lorrie McGill SNX, Omaha, Nebraska
John McGinty Reid Hospital, Richmond, Indiana
Prabodh Mehta Central Cardiology Associates, Elizabethtown, Kentucky
Michael Melucci South Texas Cardiovascular Consultants, PLLC, Kerrville, Texas
Gary Miller Cardiology Consultants of Danville, Inc., Danville, Virginia
Alan Miller Alta Pharmaceutical Research Center, Dunwoody, Georgia
Randall Miller Horizon Research Group of Opelousas LLC, Eunice, Louisiana
Northwell Health Physician Partners Cardiology, Manhasset, New
Guy Mintz
York
Jill Miracle SNX, Akron, Ohio
David Mishkin InvesClinic, Fort Lauderda, Florida
Patrick Moriarty University of Kansas Medical Center Research Institute, Inc., Kansas
City, Kansas
 35
Pamela Morris Medical University of South Carolina, Charleston, South Carolina
John Morytko South Florida Research Group, LLC, Miami, Florida
Assad Mouhaffel Clinical Trials of America LA, LLC, Monroe, Louisiana
Angel Mulkay Mulkay Cardiology Consultants PC, Teaneck, New Jersey
Linda Murray SNX, Pinellas Park, Florida
Richard Myers St. Johns Center for Clinical Research, St. Augustine, Florida
Venkatesh Nadar Capital Area Research, LLC, Camp Hill, Pennsylvania
William Nelson Health Partners Institute for Education and Research, St. Paul,
Minnesota
Paul Nugent SNX, Cincinnati, Ohio
Lazaro Nunez New Horizon Research Center, Inc, Miami, Florida
Margarita Nunez SNX, New York, New York
Larry Odekirk Lynn Institute of Denver, Aurora, Colorado
Henry Paez Pharmax Research Clinic, Miami, Florida
Bryce Palchick Preferred Primary Care Physicians, Inc., Pittsburgh, Pennsylvania
John Pasquini Novant Health and Vascular Institute Research, Charlotte, North
Carolina
Ramachandra Patak California Medical Research Associates Inc, Northridge, California
Laura Pearlman SNX, Chicago, Illinois
Isabel Pereira SNX Cassidy Medical Group, Carlsbad, CA
Isabel Pereira Synexus Clinical Research US, Inc., Vista, California
Walter Pharr Medication Management, LLC, Greensboro, North Carolina
Roland Phillips Saratoga Springs Assoc., PC, Saratoga Springs, New York
Mark Pirwitz Seton Heart Institute, Austin, Texas
Ramana Podugu Aultman Hospital, Canton, Ohio
Daniel Pomposini Danville Internal Medicine, Danville, Virginia
Orlando Portal JSV Clinical Research Study, Inc, Tampa, Florida
Cardiology Associates of Fairfield County, PC, Stamford,
Edward Portnay
Connecticut
Ranganatha Potu Nature Coast Clinical Research-Crystal River, Crystal River, Florida
Kevin Pounds SNX, Tucson, Arizona
Rakesh Prashad Ocala Research Institute, Inc., Ocala, Florida
Bharathi Pulla Clinical Investigation Specialists, Inc., Kenosha, Wisconsin
Drew Purdy Black Hills Cardiovascular Research, Rapid City, South Dakota
Kathleen Quealy MetroHealth System, Cleveland, Ohio
Arshed Quyyumi Emory University Hospital, Atlanta, Georgia
David Ramstad Hampton Roads Center for Clinical Research, Suffolk, Virginia
William Randall PriMed Clinical Research, Dayton, Ohio
Preet Randhawa NJ Heart, Linden, New Jersey
Vijay Rao Indiana Heart Physicians, Indianapolis, Indiana
Naveed Razzaque Synexus Clinical Research US, Inc., Bridgeton, Missouri
Christopher Recknor Center for Advanced Research & Education, Gainesville, Georgia
Javier Reyna Sweet Hope Research Specialty, Hialeah, Florida
Michele Reynolds SNX, Dallas, Texas
Kenneth Rich Syrentis Clinical Research, Santa Ana, California
 36
James Rider Cardiology Associates of Bellin Health, Green Bay, Wisconsin
Ernie Riffer SNX, Phoenix, Arizona
John Rubino PMG Research of Raleigh LLC, Raleigh, North Carolina
James Ruhlmann Hutchinson Clinic, Hutchinson, Kansas
Lars Runquist PMG Research of Charleston, Mount Pleasant, South Carolina
Fadi Saba Professional Health Care of Pinellas, St. Petersburg, Florida
Kenneth Sabatino Clearwater Cardiovascular & Interventional Consultants, Safety
Harbor, Florida
Jay Sandberg Oakland Medical Research Center, Troy, Michigan
Branislav Schifferdecker Oklahoma Heart Hospital Research Foundation, Oklahoma City,
Oklahoma
John Schmedtje Roanoke Heart Institute PLC, Roanoke, Virginia
Dwayne Schmidt Cardiovascular Health Clinic, Oklahoma City, Oklahoma
Derek Schroder PMG Research of Cary, LLC, Cary, North Carolina
Timothy Schuchard CentraCare Heart & Vascular Center, Saint Cloud, Minnesota
Randall Severance SNX, Chandler, Arizona
Amit Shah Piedmont Research Partners, Indian Land, South Carolina
Parag Shah Capital Cardiology Associates, Albany, New York
Priyavadan Shah Clinical Trials of America, Inc., Cary, North Carolina
Mohammad Shoukfeh Texas Cardiac Center, Lubbock, Texas
Kevin Silver Summa Health System, Akron, Ohio
William Simon Alliance for Multispecialty Research, LLC, Wichita, Kansas
Narendra Singh NSC RESEARCH, Johns Creek, Georgia
Harvey Snyder Cardiovascular Associates of the Delaware Valley, Haddon Heights,
New Jersey
Carl Sofley AnMed Health IMA, Anderson, South Carolina
Joseph Soufer Chase Medical Research, LLC, Hamden, Connecticut
Douglas Spriggs Clearwater Cardiovascular Consultants, Clearwater, Florida
Venkatraman Srinivasan Allegheny Valley Hospital Pharmacy, Natrona Heights, Pennsylvania
Michael Stephens Fleming Island Center for Clinical Research, Fleming Island, Florida
Mark Stich Westside Center for Clinical Research, Jacksonville, Florida
James Strader UCH-MHS, Colorado Springs, Colorado
David Stricklin Four Rivers Clinical Research, Inc, Paducah, Kentucky
David Strobl Sparrow Clinical Research Institute, Lansing, Michigan
David Suh Atlanta Heart Specialists, LLC, Tucker, Georgia
Ronald Surowitz Health Awareness, Inc., Jupiter, Florida
Jennefer Sutton VIP Trials, San Antonio, Texas
Naeem Tahirkheli South Oklahoma Heart Research Group, Oklahoma City, Oklahoma
Tahir Tak Mayo Clinic Health System, La Crosse, Wisconsin
James Talano Southwest Florida Research, LLC, Naples, Florida
Anjanette Tan Diabetes and Thyroid Center of Fort Worth, Fort Worth, Texas
Leslie Tharenos SNX, St Louis, Missouri
James Thomas Medical University of South Carolina (MUSC), Charleston, South
Carolina
Paul Thompson Hartford Hospital, Hartford, Connecticut
 37
Frank Tilli Genesys Regional Medical Center, Grand Blanc, Michigan
Hugo Toro Juno Research, LLC, Katy, Texas
Diego Torres Ormond Beach Clinical Research, Ormond Beach, Florida
Charles Treasure Cardiovascular Research Center of Knoxville, Powell, Tennessee
James Trippi Care Group At The Heart Center, Indianapolis, Indiana
Pilar Trueba Future Care Solution, LLC, Miami, Florida
Narendra Upadhyaya Research Physicians Network Alliance, Pembroke Pines, Florida
Sabino Velloze Southwest General Health Center, Middleburg Heights, Ohio
Cardiovascular Associates of the Delaware Valley, Sewell, New
Dilip Viswanath
Jersey
Center for Advanced Research Excellence LLC, Hialeah, Jupiter,
Craig Vogel
Florida
Mohammed Wahid Smart Medical Research Inc., Jackson Heights, New York
Ronald Walsh The Heart Institute at Largo, Largo, Florida
Xu Wang Rockford Cardiovascular Associates, Rockford, Illinois
Jeffrey Wayne Clinical Trials Research, Lincoln, California
Brian Webster Wilmington Health, Wilmington, North Carolina
Debra Weinstein Atlantic Clinical Research Collaborative, Boynton Beach, Florida
Troy Weirick Midwst Cardio Research and Education Foundation, Elkhart, Indiana
Jack Whitaker Wellmont CVA Heart Institute, Greeneville, Tennessee
Weston Whittington Medical Center of the Rockies Foundation, Ft. Collins, Colorado
Bram Wieskopf North Georgia Clinical Research, Woodstock, Georgia
Kenneth Williams Saint Agnes Medical Group, Baltimore, Maryland
Scott Wilson Partners in Clinical Research, Cumberland, Rhode Island
Liwa Younis Gateway Cardiology, PC, Jerseyville, Illinois
Jeffrey Zacher SNX, Phoenix, Arizona
Zahid Zafar Wellness Clinical Research Associates, McKinney, Texas

Author Name
Steven E Nissen, M.D.
A. Michael Lincoff, M.D.
Danielle Brennan, M.S.
Kausik K. Ray, M.D., M.Phil.*
Denise Mason, B.S.N.
John J. P. Kastelein, M.D., Ph.D.
Paul D. Thompson, M.D.
Peter Libby, M.D.
Leslie Cho, M.D.
Jorge Plutzky, M.D.
Harold Edward Bays M.D.
Patrick M. Moriarty, M.D.
Venu Menon, M.D.
Diederick E. Grobbee, M.D., Ph.D.
Michael J. Louie, M.D., M.P.H., M.Sc.
Chien-Feng Chen, Ph.D.
Na Li, Ph.D.
LeAnne Bloedon, M.S.
Paula Robinson, B.S., M.S.
Maggie Horner, B.A., M.B.A.
William J. Sasiela, Ph.D.
Stephen J. Nicholls, M.B.B.S., Ph.D.
Jackie McCluskey, R.N.
Deborah Davey, R.N.
Pedro Fajardo Campos, M.D.
Predrag Petrovic, M.D.
Jan Fedacko, M.D., Ph.D.
Witold Zmuda, M.D., Ph.D.
Yury Lukyanov, M.D.
*Prof Ray is supported by the Imperial NIHR Biomedical Research Centre
38
Author Affiliation
Cleveland Clinic
Cleveland Clinic
Cleveland Clinic
Imperial College London
Cleveland Clinic
University of Amsterdam Academic Medical
Center
Hartford Hospital
Brigham and Women's Hospital
Harvard Medical School
Cleveland Clinic
Brigham and Women's Hospital
Louisville Metabolic and Atherosclerosis
Research Center
University of Kansas Medical Center
Cleveland Clinic
University Medical Center Utrecht, Julius
Clinical Academic Research Organization
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Esperion Therapeutics, Incorporated
Victorian Heart Institute, Monash University
Cleveland Clinic
Cleveland Clinic
Centro de Investigacion Cardiovascular y
Metabolica
General Hospital Sveti Luka
Centre of Clinical and Preclinical Research
MEDIPARK, Pavol Jozef Safarik University
Medicome Sp. z o.o.
Pavlov First Saint Petersburg State Medical
University
 39
Table S1. Expanded Demographic and Baseline Characteristics of Patients*
Characteristic Bempedoic Acid Placebo
(N=6992) (N=6978)
Age (yrs) 65.5±9.1 65.5±8.9
Age, n (%)
<65 yrs. 2859 (40.9) 2907 (41.7)
≥65 to < 75 yrs 3070 (43.9) 3027 (43.4)
≥75 yrs 1063 (15.2) 1044 (15.0)
Females, n (%) 3361 (48.1) 3379 (48.4)
Race, n (%)
White 6397 (91.5) 6335 (90.8)
Black or African American 156 (2.2) 172 (2.5)
Asian 130 (1.9) 136 (1.9)
American/Mexican Indian or Alaska Native 240 (3.4) 247 (3.5)
Native Hawaiian or Other Pacific Islander 20 (0.3) 17 (0.2)
Other 1 (<0.1) 1 (<0.1)
Multiple 48 (0.7) 70 (1.0)
Ethnicity, n (%)
Hispanic or Latino 1190 (17.0) 1143 (16.4)
Body-mass index, kg/m2 29.9±5.2 30.0±5.2
LDL-Cholesterol mg/dL, mean (SD) 139.0 (34.9) 139.0 (35.2)
LDL-Cholesterol category, n (%)
<130 mg/dL 3074 (44.0) 3089 (44.3)
≥130 mg/dL to <160 mg/dL 2213 (31.7) 2250 (32.2)
≥160 mg/dL 1705 (24.4) 1639 (23.5)
hsCRP mg/L, median (IQR) 2.3 (1.2-4.5) 2.3 (1.2-4.5)
hsCRP category, n (%)
<2 mg/dL 3070 (43.9) 3071 (44.0)
≥2 mg/dL 3847 (55.0) 3840 (55.0)
Missing 75 (1.1) 67 (1.0)
HDL-Cholesterol mg/dL, mean (SD) 49.6 (13.3) 49.4 (13.3)
Non-HDL-Cholesterol mg/dL, mean (SD) 173.8 (39.5) 173.9 (40.2)
Total Cholesterol mg/dL, mean (SD) 223.5 (40.6) 223.3 (41.1)
Triglycerides mg/dL, median (IQR) 159.5 (118.0-216.5) 158.5 (118.0-215.0)
Baseline eGFR mL/min/1.73m2, n (%)
≥ 90 1216 (17.4) 1233 (17.7)
≥60 to < 90 4322 (61.8) 4282 (61.4)
≥30 to < 60 1437 (20.6) 1444 (20.7)
Cardiovascular risk category, n (%)
Primary prevention 2100 (30.0) 2106 (30.2)
Reynolds Risk Score >30% or a SCORE Risk
868 (12.4) 922 (13.2)
Score of >7.5% over 10 years
Coronary artery calcium score >400 AU 86 (1.2) 55 (0.8)
 40
Patients with type 1 or 2 diabetes, aged >65
1150 (16.4) 1187 (17.0)
(women) or >60 years (men)
Unknown 104 (1.5) 85 (1.2)
Secondary prevention 4892 (70.0) 4872 (69.8)
Coronary artery disease 3574 (51.1) 3536 (50.7)
Peripheral arterial disease 794 (11.4) 830 (11.9)
Cerebrovascular atherosclerotic disease 1027 (14.7) 1040 (14.9)
Glycemic status, n (%)
No diabetes 3848 (55.0) 3749 (53.7)
Normoglycemic 937 (13.4) 864 (12.4)
Prediabetes§ 2911 (41.6) 2885 (41.3)
Diabetes‡ 3144 (45.0) 3229 (46.3)
Inadequately controlled diabetes† 1356 (19.4) 1369 (19.6)
Baseline Lipid Modifying Therapies, n (%)
Statins 1601 (22.9) 1573 (22.5)
Ezetimibe 803 (11.5) 809 (11.6)
Bile acid sequestrants 48 (0.7) 36 (0.5)
Fibrates 371 (5.3) 393 (5.6)
PCSK9 inhibitors 35 (0.5) 50 (0.7)
Niacin derivatives 33 (0.5) 50 (0.7)
*To convert the values for cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for
triglycerides to millimoles per liter, multiply by 0.01129. LDL-C denotes low density lipoprotein cholesterol,
hsCRP high-sensitivity C-reactive protein, HDL-C high density lipoprotein cholesterol.
§Patients at baseline with no medical history of diabetes, no prior use of glucose-lowering medication, and a
HbA1C measurement of 5.7% to 6.4%, or 1 or more measurements of fasting glucose of 100 mg/dL (5.6
mmol/L) to 125 mg/dL (6.9 mmol/L), but not more than 1 value of fasting glucose ≥126 mg/dL (7.0 mmol/L).
‡
At baseline, medical history of diabetes, prior glucose-lowering medication, HbA1C measurement ≥6.5%, or
two or more measurements of fasting glucose ≥126 mg/dL (7.0 mmol/L).
†Patients with diabetes and an HbA1C of 7.0% or greater at baseline.
 41

Table S2. Additional Secondary Time to Event Efficacy End Points and Selected Tertiary Lipid Endpoints

Additional secondary time-to-event end points

Outcome Bempedoic Acid Placebo Hazard Ratio

(N=6992) (N=6978) (95% CI)
number of patients (%)
Non-fatal MI 236 (3.4) 317 (4.5) 0.73 (0.62-0.87)
Fatal MI 29 (0.4) 21 (0.3) 1.38 (0.79-2.42)
Non-fatal stroke 119 (1.7) 144 (2.1) 0.82 (0.64-1.05)
Fatal stroke 18 (0.3) 16 (0.2) 1.12 (0.57-2.20)
Fatal and nonfatal non-hemorrhagic stroke 118 (1.7) 150 (2.1) 0.78 (0.61-0.99)
Fatal and nonfatal hemorrhagic stroke 20 (0.3) 9 (0.1) 2.21 (1.01-4.85)

Selected Tertiary Lipid Endpoints Bempedoic Acid Placebo

(N=6992) (N=6978)
Observed mean±SD or median (IQR)
Percent change from baseline to Month 6 in non-HDL-C -17.2%±21.2 -0.4%±21.4
Percent change from baseline to Month 12 in non-HDL-C -17.1%±22.0 -2.0%±22.3
Percent change from baseline to Month 24 in non-HDL-C -16.2%±24.3 -3.8%±24.5
Percent change from baseline to Month 6 in total cholesterol -16.9%±16.7 -0.6%±16.3
Percent change from baseline to Month 12 in total cholesterol -14.8%±17.3 -1.8%±17.1
Percent change from baseline to Month 6 in HDL-C -5.8%±18.0 0.7%±15.1
 42

Percent change from baseline to Month 12 in HDL-C -5.7%±18.9 0.7% ± 16.2

Percent change from baseline to Month 6 in triglycerides -3.4% (-23.7% to 22.1%) -1.7% (-19.5% to 19.5%)
Percent change from baseline to Month 12 in triglycerides -4.8% (-24.8% to 21.6%) -2.3% (-20.8% to 20.4%)
Change from baseline to Month 6 in HbA1c (%)
All patients -0.003±0.6 0.05±0.7
Inadequately Controlled Diabetes at Baseline -0.20±1.0 -0.14±1.2
Change from baseline to Month 12 in HbA1c (%)
All patients 0.04±0.7 0.0±0.7
Inadequately Controlled Diabetes at Baseline -0.06±1.3 -0.03±1.2
Change from baseline to Month 6 in fasting glucose (mg/dL)
All patients -1.0 (-9.0 to 7.0) 0.5 (-7.5 to 8.5)
Inadequately Controlled Diabetes at Baseline -4.0 (-32.0 to 25.0) 0.5 (-26.5 to 29.0)
Change from baseline to Month 12 in fasting glucose (mg/dL)
All patients 0.0 (-8.0 to 8.5) 1.0 (-7.0 to 10.0)
Inadequately Controlled Diabetes at Baseline -2.8 (-32.5 to 30.5) 0.5 (-28.3 to 29.0)
 43
Table S3. Detailed Description of Investigator-Reported Muscle Adverse Events using Medical
Dictionary for Regulatory Affairs (MEDRA) Terminology

Bempedoic Acid Placebo

(N=7001) (N=6964)
n (%) n (%)
Any Muscle Disorder Adverse Event 1052 (15.0) 1070 (15.4)
Myalgia 393 (5.6) 471 (6.8)
Pain in the extremity 296 (4.2) 296 (4.3)
Muscle spasms 275 (3.9) 240 (3.4)
Blood creatine phosphokinase increased 161 (2.3) 140 (2.0)
Muscular weakness 60 (0.9) 63 (0.9)
Musculoskeletal discomfort 8 (0.1) 6 (0.1)
Myopathy 5 (0.1) 6 (0.1)
Muscle fatigue 3 (<0.1) 8 (0.1)
Muscle tightness 3 (<0.1) 4 (0.1)
Myositis 3 (<0.1) 7 (0.1)
Red blood cells urine positive 2 (<0.1) 3 (<0.1)
Skeletal Muscle Events Leading to Drug
Discontinuation
Muscle Disorder Adverse Event 202 (2.9) 221 (3.2)
Myalgia 124 (1.8) 129 (1.9)
Pain in the extremity 35 (0.5) 31 (0.4)
Muscle spasms 31 (0.4) 49 (0.7)
Muscular weakness 8 (0.1) 11 (0.2)
Blood creatine phosphokinase increased 5 (0.1) 5 (0.1)
Myopathy 2 (<0.1) 2 (<0.1)
Musculoskeletal discomfort 1 (<0.1) 0
Myositis 0 1 (<0.1)
 44
Table S4. Summary of Investigator-Reported Rhabdomyolysis Cases
43-26028008 43-01073003 43-01090002 43-01128017 43-01522002 43-08030016 43-08044004 43-08713015
Relevant Clinical Worsening History of Diagnosed with Ongoing History of Hyperkalemia Bilateral pain Two adverse
Presentation gastritis, rhabdomyolysis concurrent sepsis. pemphigoid, polymyalgia and renal in thigh, calf reports of
duodenitis, on statins, Patient initiated rheumatica, impairment and back rhabdomyolysis
and started unconscious on Bactrim 17 suffered fall concurrent both post
pancreatitis 6 exercising prior floor for extended days prior to and with event physical
days prior to to onset of event period event, 9 hospitalized activity§
event, possible hours on
relationship to floor
exercise overnight
Bempedoic Bempedoic Bempedoic Bempedoic Bempedoic Bempedoic
Treatment Bempedoic Acid Placebo
Acid Acid Acid Acid Acid Acid
Statin N N N N N Y (mod. Int) Y (very low) Y (very low)
Muscle symptoms Yes Yes Yes Yes No No Yes NR
Peak CK Level 2.6X ULN 11X ULN* 119X ULN * 99X ULN * 5X ULN 1.7X ULN 10X ULN* 7X/12X ULN
Met Protocol Threshold for
No Yes Yes Yes Yes No Yes Yes
Repeat CK measurement†
CK Repeated NA Yes No Yes No NA No Yes
CK Confirmed >10 X ULN NA No NA No NA NA NA No
Change in creatinine‡ No No Yes Yes NR Yes NR No
Myoglobinemia or
NR NR NR NR NR NR NR NR
Myoglobinuria
Reported concurrent Renal Yes, acute kidney Yes, acute Yes, renal Yes, renal
No No No No
adverse event injury kidney failure failure impairment
Interrupted,
restarted after
NA NA Interrupted,
20 days; Interrupted,
(stopped 15 (stopped 178 Permanently subsequently
Drug Action permanently subsequently None None
days prior to days prior to discontinued restarted after
discontinued restarted
event) event) both events
due to other
adverse event
Hospitalization No No Yes Yes Yes No No No
IV Fluids, IV Fluids,
Management NR Oral rehydration NR None None None
electrolytes electrolytes
Both
Recovered/ Recovered/ Recovered/ Recovered/ Recovered/ Recovered/
Outcome Unknown recovered/
resolved resolved resolved resolved resolved resolved
resolved
 45
Definitely Not related, Not related, Not related, Not related, Possibly Both not
Investigator assessment Not related
related exercise sepsis bactrim fall related related
NA (non- NA (non- NA
Sponsor assessment Not related Not related Not related Not related Not related
serious) serious) (non-serious)
*Local lab. NR denotes not reported; NA, not applicable; CK, creatine kinase.
§
Data presented represents the information related to both reported rhabdomyolysis adverse events.
†Protocol specified monitoring and management of elevated creatine kinase, instructed investigators to conduct a repeat confirmatory assessment as soon as
reasonably possible when a patient experiences a CK elevation >5 X upper limit of normal, preferably within 3 to 7 days
‡
Increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days.
Note: The European Atherosclerosis Society Consensus Panel1 defines rhabdomyolysis as CK elevation greater than 40x ULN with myoglobinemia or
myoglobinuria. Two patients (43-01090002 and 43-01128017) met this definition, one in the bempedoic acid arm and one in the placebo arm. Both cases
were assessed as not related to drug treatment by the investigator and the sponsor
 46
Figure S1 Flow of Patients through the Trial
47
48
49
 50

Figure S3. Prespecified Subgroup Analyses for the Primary Endpoint

51
 52

Subject Inclusion Criteria

Each patient must meet the following criteria to be eligible for this study.
1. Provision of signed informed consent prior to any study-specific procedure
2. Patient-reported SI due to an adverse safety effect that started or increased during
statin therapy and resolved or improved when statin therapy was discontinued resulting
in an inability to tolerate:
• 2 or more statins at any dose, or
• 1 statin at any dose and unwilling to attempt a second statin or advised by a
physician to not attempt a second statin.
Please note that patients currently tolerating very low dose statin therapy (an average
daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin
<20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered
to be intolerant to that low dose statin. Patients may continue taking very low dose
statin therapy throughout the study provided that it is stable (used for at least 4 weeks
prior to screening) and well tolerated.
3. Written confirmation by both patient and investigator that the patient is statin
intolerant as defined above, aware of the benefit of statin use to reduce the risk of
MACE including death, and also aware that many other patients who are unable to
tolerate a statin are able to tolerate a different statin or dose.
4. Age ≥18 years or legal age of majority based on regional law, whichever is greater, and
≤85 years at Week -5 (Visit S1).
5. Men and nonpregnant, nonlactating women. Women must be one of the following:
• Naturally postmenopausal defined as ≥1 year without menses and:
- ≥55 years, or
- <55 years with follicle-stimulating hormone (FSH) ≥40.0 IU/L, or
• Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal
ligation, or
• Women of childbearing potential willing to use an acceptable method(s) of birth
control during the study and for 30 days after the end of treatment, including:
- oral, topical, injectable, or implantable birth control medications,
- placement of an intrauterine device with or without hormones,
- barrier methods including condom or occlusive cap with spermicidal foam or
spermicidal jelly,
- vasectomized male partner who is the sole partner for this patient,
 53
- true abstinence that is in line with the preferred and usual lifestyle of the patient
(periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation
methods], declaration of abstinence for the duration of the study or withdrawal
are not acceptable methods of true abstinence).
There are no protocol-specific birth control requirements for men with partners who are
able to become pregnant.
6. Fasting LDL-C ≥100 mg/dL (2.6 mmol/L) at Week -5 (Visit S1) while taking stable
(4 weeks prior to Visit S1) and optimized background LDL-C-lowering therapies that may
include very low dose statin (see definition above), ezetimibe, niacin, bile acid resins,
fibrates, and/or PCSK9 inhibitors.
Note: A single repeat of LDL-C may be completed prior to initiation of the single-blind
Run–in Period. For those patients who have a repeat LDL-C, the repeat value will be
used to determine eligibility.
7. History of, or at high risk for, CVD including documented evidence of one or more of the
following:
a. Documented history of CVD (i.e., secondary prevention)
- Coronary artery disease, defined by:
○ MI (either ST-elevation MI or non-ST-elevation MI) occurring greater than
90 days prior to screening, or
○ Percutaneous coronary or surgical coronary revascularization, occurring
greater than 90 days prior to screening, or
○ Angiographic stenosis of ≥50% in a least 1 major coronary artery (native or
graft vessel), as documented by selective coronary angiography or computed
tomography angiography (CTA), or
- Symptomatic peripheral arterial disease (PAD), defined by:
○ Peripheral vascular disease with symptoms of claudication or resting limb
ischemia with either ankle brachial index <0.9 or angiogram (including CTA)
showing ≥50% stenosis (ankle brachial index will be measured after a period
of rest and with the patient in the supine position using a Doppler device), or
○ Peripheral arterial revascularization (surgical or percutaneous), occurring
greater than 90 days prior to screening, or
○ Abdominal aortic aneurysm confirmed by imaging or aortic aneurysm repair,
occurring greater than 90 days prior to screening, or
○ Lower extremity amputation due to peripheral vascular disease, occurring
greater than 90 days prior to screening, or
- Cerebrovascular atherosclerotic disease defined by:
○ Ischemic stroke occurring greater than 90 days prior to screening, or
 54
○ Carotid endarterectomy, carotid stenting, or more than 70% stenosis in a
carotid artery determined by carotid ultrasound or angiogram (Note: If
stenosis assessed by carotid ultrasound is reported as range between
60%-79%, patient may qualify only if internal carotid artery peak systolic
velocity is >230 cm/sec), occurring greater than 90 days prior to screening, or
b. High risk for a CVD event (i.e., high-risk primary prevention)
- Reynolds Risk score >30% or a SCORE Risk score >7.5% over 10 years or
- Coronary artery calcium score >400 Agatston units (AU) at any time in the past,
or
- Patients with type 1 or type 2 diabetes, aged >65 years (women) or >60 years
(men).

Subject Exclusion Criteria

Patients who meet any of the following criteria will not be eligible to participate:
1. Total fasting TG >500 mg/dL (5.6 mmol/L) at Week -5 (Visit S1).
Note: A single repeat of TG may be completed prior to initiation of the single-blind
Run-in Period. For those patients who have a repeat TG, the repeat value will be used
to determine eligibility.
2. Renal dysfunction or a glomerulopathy defined as either nephritic or nephrotic
syndrome, including estimated glomerular filtration rate (eGFR; using central laboratory
determined Modification of Diet in Renal Disease [MDRD] formula) <30 mL/min/1.73 m2
at Week -5 (Visit S1).
Note: A single repeat of eGFR may be completed prior to randomization. For those
patients who have a repeat eGFR, the repeat value will be used to determine eligibility.
3. Forms of CVD that include any of the following:
a. Recent (within 90 days prior to or during screening) acute CVD events including, but
not only transient ischemic attack (TIA), MI, coronary revascularization, peripheral
arterial revascularization, ischemic stroke, carotid endarterectomy, carotid stenting,
b. Recent (within 90 days of screening) unstable or symptomatic cardiac arrhythmia
(including any associated medication changes). Patients with stable well-controlled
atrial arrhythmias will be allowed to participate in the study.
c. Patients with implantable pacemakers or automatic implantable cardioverter
defibrillators may be considered if deemed by the investigator to be stable for
greater than 90 days prior to screening,
d. New York Heart Association (NYHA) Functional Classification Class IV heart failure,
e. Uncontrolled hypertension, defined as mean sitting systolic blood pressure (SBP)
≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg,
Note: At the discretion of the investigator, BP medications can be adjusted and/or
additional assessment of BP may be completed prior to randomization, with the
 55
repeat assessment value used to determine eligibility. Alternatively, patients can be
rescreened if BP status has changed.
f. Planned coronary revascularization (patient may rescreen 3 months
post-procedure).
4. HbA1C ≥10% at Week -5 (Visit S1).
5. Uncontrolled hypothyroidism, including thyroid-stimulating hormone (TSH) >1.5 × the
upper limit of normal (ULN) at Week -5 (Visit S1). Note: At the discretion of the
investigator, thyroid replacement therapy can be adjusted and/or additional
measurement of TSH may be completed prior to randomization, with the repeat TSH
value used to determine eligibility.
6. Liver disease or dysfunction, including:
a. Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies
(HCV-ABVivi) at Week -4 (Visit S2), or
b. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.0 × ULN
at Week -5 (Visit S1).
Note: At the discretion of the investigator, a single repeat of ALT and/or AST may be
completed prior to randomization. For those patients who have a repeat ALT and/or
AST, the repeat value will be used to determine eligibility. Also, if test for Hepatitis C
antibody is positive, but optional reflexive test for Hepatitis C RNA is negative, patient
can be enrolled.
7. Gastrointestinal conditions or procedures (including weight loss surgery; e.g., Lap-Band®
or gastric bypass) that may affect drug absorption.
8. Hematologic or coagulation disorders or a hemoglobin (Hgb) level <10 g/dL at Week -5
(Visit S1).
9. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in
the past 5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and
cervical carcinoma in situ are allowed.
10. Unexplained creatine kinase (CK) >3 × ULN at Week -5 (Visit S1) (i.e., not associated with
recent trauma or physically strenuous activity). Patients with an explained CK elevation
must have single repeat CK ≤3 × ULN prior to randomization.
11. History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine
abuse. Patients with amphetamine derivatives prescribed by and under the care of a
health care practitioner can be enrolled after evaluation by the investigator.
12. Blood transfusion for any reason within 30 days prior to randomization.
13. Use of any experimental or investigational drugs within 30 days prior to screening or
5 half-lives, whichever is longer.
14. Randomization into another Phase 3 bempedoic acid clinical study.
 56
15. Use of, or a plan to initiate, these prohibited therapies/supplements during the study:
• Mipomersen (must be stopped at least 6 months prior to Week -5 [Visit S1]),
lomitapide or apheresis therapy (must be stopped at least 3 months prior to
Week -5 [Visit S1]),
• Red yeast rice (must be stopped at least 2 weeks prior to Week -5 [Visit S1]),
• Statins are prohibited at average daily doses of rosuvastatin ≥5 mg, atorvastatin
≥10 mg, simvastatin ≥10 mg, lovastatin ≥20 mg, pravastatin ≥40 mg, fluvastatin
≥40 mg, or pitavastatin ≥2 mg.
16. Planned initiation or dose adjustments of these allowed drugs prior to screening and
during the clinical trial (stable use of these drugs is permitted):
• Statins are allowed only at average daily doses of rosuvastatin <5 mg, atorvastatin
<10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin
<40 mg, or pitavastatin <2 mg (must be stable at least 4 weeks prior to Week -5
[Visit S1]) ,
• Other lipid-regulating drugs or supplements must be stable at least 4 weeks prior to
Week -5 [Visit S1]),
• PCSK9 inhibitors (must be stable at least 12 weeks prior to Week -5 [Visit S1]).
17. Lack of adherence (i.e., less than 80% of planned doses) with IMP (single-blind placebo)
during the Run-in Period.
18. Lack of tolerance with IMP (single-blind placebo) during the Run-in Period.
19. A medical or situational (i.e., geographical) finding that in the investigator’s opinion may
compromise the patient’s safety or ability to complete the study.
20. An employee or contractor of the facility conducting the study, or a family member of
the Principal Investigator, Co-Investigator, or Sponsor.
21. Pregnant, breastfeeding, or intending to become pregnant within 30 days after study
completion or last dose of IMP.
 57

STATIN INTOLERANCE CONFIRMATION FORM

1. Patient Identification (Please Print or Type)

Name:

Initials:

Screening Number:

Patient

My doctor has recommended that I take a medication (called a statin) to reduce the bad
cholesterol (fats) in my blood. My doctor has told me that a statin would reduce my risk of a
heart attack or stroke and the risk of death. However, I am not taking a statin (or I am taking a
statin only at a very low dose) because of side effects. These side effects began or became worse
when I was taking the statin and then went away or improved when I stopped taking it or
decreased the dose. I can’t tolerate these medications (called statins) even though I know they
would reduce my risk of a heart attack or stroke or death. My doctor has explained and I am
aware that many patients who are unable to tolerate a single statin medication may also be able
to tolerate a different statin or dose.

Date Signature of Patient

Principal Investigator

For the purposes of the 1002-043 clinical study, in my opinion, this patient is unable to tolerate
statin therapy (except possibly at very low average daily doses of atorvastatin <10 mg, fluvastatin
<40 mg, lovastatin <20 mg, pravastatin <40 mg, pitavastatin <2 mg, rosuvastatin <5 mg or
simvastatin <10 mg) based on my review of the medical and medication histories and discussion
with the patient.

Date Signature of Principal Investigator

 58

Definitions of the Components of the Primary Endpoint

1. Death

All events with an outcome of death will be adjudicated to determine whether the death was
related to a CV cause, a non-CV cause or undetermined cause. Death is classified into 1 of
2 categories: 1) cardiovascular death; and 2) noncardiovascular death.
Primary Cause of Death
Cardiovascular Death
Cardiovascular death includes death resulting from: an acute MI, sudden cardiac death, death
due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures,
death due to CV hemorrhage, and death due to other CV causes.
CV mortality will be classified more specifically (MI, sudden cardiac death, etc.) as follows:
CV: Acute MI:
Death by any cardiovascular mechanism (arrhythmia, sudden death, HF, stroke, pulmonary
embolus, peripheral arterial disease) within 30 days after an acute MI, related to the immediate
consequences of the MI, such as progressive HF or recalcitrant arrhythmia. There may be
assessable (attributable) mechanisms of cardiovascular death during this time period, but for
simplicity, if the cardiovascular death occurs within 30 days of an acute MI, it will be considered
a death due to MI.
Note: Acute MI should be verified to the extent possible by the diagnostic criteria outlined for
acute MI or by autopsy findings showing recent MI or recent coronary thrombosis.
Death resulting from a procedure to treat an MI (percutaneous coronary intervention [PCI] or
coronary artery bypass graft [CABG]), or to treat a complication resulting from MI, should also
be considered death due to acute MI.
Death resulting from an elective coronary procedure to treat myocardial ischemia (i.e., chronic
stable angina) or death due to a MI that occurs as a direct consequence of a cardiovascular
investigation/procedure/operation should be considered as death due to a cardiovascular
procedure.
Death where symptoms suggestive of myocardial ischemia are present and with (presumed)
new ischemic or new left bundle branch block (LBBB) on electrocardiogram (ECG), but where
death occurs before cardiac biomarkers can be obtained or could rise or (in rare cases) were
not collected.
CV: Sudden Cardiac Death
Death that occurs unexpectedly, and not within 30 days of an acute MI.
Note: Sudden cardiac death includes the following scenarios:
a. Death witnessed and occurring without new or worsening symptoms
 59
b. Death witnessed within 60 minutes of the onset of new or worsening cardiac
symptoms, unless the symptoms suggest acute MI
c. Death witnessed and attributed to an identified arrhythmia (e.g., captured on an
electrocardiographic recording, witnessed on a monitor, or unwitnessed but found
on Informed Consent Document [ICD] review)
d. Death after unsuccessful resuscitation from cardiac arrest(e.g., ICD unresponsive
sudden cardiac death, pulseless electrical activity arrest)
e. Death after successful resuscitation from cardiac arrest and without identification of
a specific cardiac or noncardiac etiology
f. Unwitnessed death in a subject seen alive and clinically stable ≤24 hours before
being found dead without any evidence supporting a specific noncardiovascular
cause of death (information about the patient’s clinical status preceding death
should be provided, if available)
Unless additional information suggests an alternate specific cause of death (e.g., Death due to
Other Cardiovascular Causes), if a patient is seen alive ≤24 hours before being found dead,
sudden cardiac death should be recorded. For patients who were not observed alive within
24 hours of death, undetermined cause of death should be recorded (e.g., a subject found dead
in bed, but who had not been seen by family members for >24 hours).
CV: HF (Heart Failure)
Death associated with clinically worsening symptoms and/or signs of HF regardless of HF
etiology.
Note: Deaths due to HF can have various etiologies, including single or recurrent MIs, ischemic
or nonischemic cardiomyopathy, hypertension, or valvular disease.
CV: Stroke
Death after a stroke that is either a direct consequence of the stroke or a complication of the
stroke and occurs within 30 days after an acute stroke. Note: Acute stroke should be verified to
the extent possible by the diagnostic criteria outlined for stroke.
CV: CV Procedure
Death caused by the immediate complication(s) of a cardiovascular procedure.
CV: CV Hemorrhage
Death related to hemorrhage such as a nonstroke intracranial hemorrhage (e.g., subdural
hematoma) nonprocedural or nontraumatic vascular rupture (e.g., aortic aneurysm), or
hemorrhage causing cardiac tamponade.
CV: CV Other
CV death not included in the above categories but with a specific, known cause (e.g., PE, PAD).
CV: Undetermined Cause of Death
Undetermined cause of death applies to patients with no/very limited documentation
pertaining to the cause of death. Attribution of causality may be limited or impossible if
information available at the time of death is minimal or non-existent.
 60

Noncardiovascular Death
When death is clearly due to a noncardiovascular cause, a cardiovascular cause of death is
excluded. Non-CV causes of death include the following:
Pulmonary
Noncardiovascular death attributable to disease of the lungs (excludes malignancy).
Renal
Noncardiovascular death attributable to renal failure.
Gastrointestinal
Noncardiovascular death attributable to disease of the esophagus, stomach, or intestines
(excludes malignancy).
Hepatobiliary
Noncardiovascular death attributable to disease of the liver, gallbladder, or biliary ducts
(excludes malignancy).
Pancreatic
Noncardiovascular death attributable to disease of the pancreas (excludes malignancy).
Infection
Noncardiovascular death attributable to an infectious disease. Note: includes sepsis.
Inflammatory/immune (including autoimmune)
Noncardiovascular death attributable to an inflammatory or immune-mediated disease or
process. Note: Includes : Includes Systemic Inflammatory Response Syndrome (SIRS),
immunological and autoimmune diseases and disorders. Includes anaphylaxis from
environmental (e.g. food) allergies.
Hemorrhage
Noncardiovascular death attributable to bleeding that is not considered cardiovascular
hemorrhage or stroke according to this classification schema.
Non-CV procedure or surgery
Death caused by the immediate complication(s) of a noncardiovascular procedure or surgery.
Trauma
Noncardiovascular death attributable to trauma. Includes homicide.
Suicide
Noncardiovascular death attributable to suicide.
Nonprescription drug reaction or overdose
Noncardiovascular death attributable to a nonprescription drug reaction or overdose. Note:
Includes anaphylaxis.
 61
Prescription Drug Reaction or overdose
Noncardiovascular death attributable to a prescription drug reaction or overdose. Note:
Includes anaphylaxis.
Neurological
Noncardiovascular death attributable to disease of the nervous system (excludes malignancy).
Note: Excludes cardiovascular death from ischemic stroke, hemorrhagic stroke, or
undetermined cause of stroke or cardiovascular hemorrhage of central nervous system.
Malignancy
Noncardiovascular death attributable to leukemia, lymphoma, or other malignancy.
Other non-CV; specify
Noncardiovascular death attributable to a cause other than those listed in this classification
(specify organ system).

2. Acute Nonfatal Myocardial Infarction

Acute MI
Clinical syndrome where there is evidence of myocardial necrosis in a clinical setting consistent
with acute myocardial ischemia.
Type 1: Spontaneous
Spontaneous clinical syndrome related to atherosclerotic plaque rupture, ulceration, fissuring,
erosion, or dissection with resulting intraluminal thrombus, and leading to decreased
myocardial blood flow or distal platelet emboli with ensuing myocyte necrosis. This
classification requires
a. Detection of a rise and/or fall of cardiac biomarker values (preferably cTn) with at
least 1 value >99th percentile of the URL and
b. At least 1 of the following:
1) Symptoms of myocardial ischemia
2) New or presumed new significant ST-segment –T-wave (ST-T) changes or new
LBBB on the ECG
3) Development of pathological Q waves on the ECG
4) Imaging evidence of new loss of viable myocardium or new regional wall motion
abnormality
5) Identification of an intracoronary thrombus by angiography or autopsy.
Notes: One or more coronary arteries may be involved. The patient may have underlying severe
CAD but on occasion may be nonobstructive coronary artery disease (CAD).
 62
Type 2: Ischemic Imbalance
Spontaneous clinical syndrome where a condition OTHER THAN CAD contributes to an
imbalance between myocardial oxygen supply and/or demand,( e.g., coronary endothelial
dysfunction, coronary artery spasm, coronary embolism, tachy-/brady-arrhythmias, anemia,
respiratory failure, hypotension, and hypertension with or without left ventricular hypertrophy
[LVH]). This classification requires:
a. Detection of a rise and/or fall of cardiac biomarker values (preferably cTn) with at least
1 value >99th percentile of the URL and
b. At least 1 of the following:
1) Symptoms of myocardial ischemia
2) New or presumed new significant ST-segment –T-wave (ST-T) changes or new
LBBB on the ECG
3) Development of pathological Q waves on the ECG
4) Imaging evidence of new loss of viable myocardium or new regional wall motion
abnormality
Type 4a: PCI related
MI associated with and occurring within 48 hours of (PCI) with elevation cardiac biomarker
values to>5 x 99th percentile of the URL in patients with normal baseline values (<99th
percentile URL) or a rise of cardiac biomarker values ≥20% if the baseline values are elevated
and are stable or falling. This classification also requires at least 1 of the following (a) symptoms
suggestive of myocardial ischemia (i.e., prolonged ischemia >20 min), or (b) new ischemic
changes on ECG or new LBBB, or (c) angiographic loss of patency of a major coronary artery or a
side branch or persistent slow or no-flow or embolization, or (d) imaging evidence of new loss
of viable myocardium or new regional wall motion abnormality.
Type 4b: Stent Thrombosis
MI associated with stent thrombosis as detected by coronary angiography or at autopsy where
symptoms suggestive of myocardial ischemia are present, and with a rise and/or fall of cardiac
biomarkers values with at least 1 value >99th percentile URL.
Type 4c: Stent restenosis
MI associated with stent restenosis as detected by coronary angiography or at autopsy,
occurring >48 hours after PCI, without evidence of stent thrombosis but with symptoms
suggestive of myocardial ischemia, and with elevation of cardiac biomarker values to >99th
percentile of the URL. This classification also requires the following:
a. Does not meet the criteria for any other classification of MI
b. Presence of a >50% stenosis at the site of previous successful stent PCI or a complex
lesion and no other significant obstructive CAD of greater severity following
1) Initially successful stent deployment, or
2) Dilation of a coronary artery stenosis with balloon angioplasty to <50% stenosis.
 63
Type 5: CABG Related
MI associated with and occurring within 48 hours of CABG surgery, with elevation of cardiac
biomarker values >10 x 99th percentile URL in patients with normal baseline cardiac biomarker
values (<99th percentile URL). This classification also requires at least 1 of the following: (a) new
pathological Q waves, new LBBB, on ECG or (b) angiographic new graft or new native coronary
artery occlusion, or (c) imaging evidence of new loss of viable myocardium or new regional wall
motion abnormality.
MI Terminology Concept
Acute MI- Symptom Onset Date-Time
Date and Time of onset of symptoms of Acute MI
Acute MI-Symptoms Acute
Presence of acute symptoms of myocardial ischemia, such as chest, upper extremity,
mandibular, or epigastric discomfort, or an ischemic equivalent such as dyspnea or fatigue.
This is one of the noncardiac marker criteria supporting the diagnosis of acute MI types 1, 2,
3, 4a, 4b, and 4c.
Acute MI-Acute Ischemic Changes on ECG
Presence of new or presumed new significant ST-segment, T-wave (ST-T) changes or new
LBBB consistent with acute myocardial ischemia. This is one of the noncardiac marker
criteria supporting the diagnosis of acute MI types 1, 2, 3, and 4.
Ischemic Changes on ECG: In the absence of LVH and LBBB pattern (or other confounder
such as a paced rhythm) on ECG, either
a) ST elevation at the J point in 2 contiguous leads with the cut-points: ≥0.1 mV in all leads
other than leads V2-V3 where the following cut-points apply: ≥0.2 mV in men ≥40 years
of age; ≥0.25 mV in men <40 years of age, or ≥0.15 mV in women; or
b) New (or presumed new) horizontal or down-sloping ST depression >0.05 mV in
2 contiguous leads and/or new T inversion >0.1 mV in 2 contiguous leads with
prominent R wave or R/S ratio >1.
LBBB: New (or presumed new) LBBB pattern on ECG
Acute MI- New Q Waves on ECG
Presence of new or presumed new pathological Q waves consistent with MI. This is one of
the noncardiac marker criteria supporting the diagnosis of acute MI types 1, 2, 4, and 5.
New Q waves: New (or presumed new) Q wave in leads V2 to V3 ≥0.02s or QS complex in
leads V2 and V3; b) Q wave ≥0.03s and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF,
or V4 to V6 in any 2 leads of a contiguous lead grouping (I, aVL; V1 to V6; II, III, aVF; V7 to
V9); or c) R wave ≥0.04 s in V1 to V2 and R/S ≥1 with a concordant positive T wave in the
absence of a conduction defect.
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Acute MI-Coronary Thrombus Present
Presence of thrombus in a major epicardial vessel consistent with an acute MI. This is one of
the noncardiac marker criteria supporting the diagnosis of acute MI type 1.
Thrombus on Angiography: In the patient with a presumed acute STEMI, the angiographic
appearance of thrombus (typically a filling defect) on angiography. This includes the
aspiration of thrombus from the infarct vessel before coronary intervention during primary
PCI for acute STEMI.
Thrombus at Autopsy: Identification of thrombus in a major epicardial vessel at autopsy.
Acute MI- Change in Noninvasive Imaging
Demonstration of a new change in myocardial viability or function consistent with MI. This
is one of noncardiac marker criteria supporting the diagnosis of acute MI types 1, 2, 4a,
and 5.
New Loss of Viable Myocardium: Noninvasive imaging evidence of a loss of viable
myocardium when compared with the most recent previous noninvasive imaging study.
New Regional Wall Motion Abnormality: Noninvasive imaging evidence of a decrease in
regional wall motion contractility compared with the most recent previous noninvasive
imaging study.
Acute MI- PCI Angiographic Complication
Occurrence of an adverse angiographic finding during PCI consistent with acute myocardial
ischemia. This is one of the noncardiac marker criteria supporting the diagnosis of acute MI
type 4a.
Loss of Major Coronary: Angiographic loss of patency of a major epicardial vessel.
Loss of Side Branch: Angiographic loss of patency of a side branch.
Slow flow/no flow/embolization: Angiographic reduction of flow into the coronary
microcirculation.
Acute MI-Acute Vessel Occlusion after CABG
Angiographic documentation of a new CABG or new native coronary artery occlusion within
48 hours of CABG surgery. This is one of the noncardiac marker criteria supporting the
diagnosis of acute MI Type 5.
Prior MI
Presence of any one of the following criteria meets the diagnosis for prior MI (before study
initiation): a) pathological Q waves with or without symptoms in the absence of
nonischemic causes b) Imaging evidence of a region of loss of viable myocardium that is
thinned and/or fails to contact, in the absence of a nonischemic cause c) Pathological
findings of a prior MI.
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3. Nonfatal Stroke and TIA

An acute episode of focal or global neurological dysfunction, caused by brain, spinal cord, or
retinal vascular injury as a result of hemorrhage or infarction.
Ischemic
An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central
nervous system tissue.
Note: Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an
ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Hemorrhagic
An acute episode of focal or global cerebral or spinal dysfunction caused by intra-parenchymal,
intra-ventricular, or subarachnoid hemorrhage.
Note: Subdural hematomas are intracranial hemorrhagic events and NOT strokes.
Undetermined
An acute episode of focal or global neurologic dysfunction caused by presumed brain, spinal
cord, or retinal vascular injury as a result of hemorrhage or infarction but with insufficient
information to allow categorization as either ischemic or hemorrhagic.
Stroke Terminology Concept
Stroke/TIA Date-Time
Date and time of the onset of a stroke/TIA.
Transient Ischemic Attack
Transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal
ischemia, without acute infarction.
Note: Persistence of symptoms is an acceptable indicator of acute infarction. The duration of
symptom persistence that will be used to distinguish between transient ischemia and acute
infarction is a duration ≥24 hours.

4. Unstable Angina Hospitalization

Unscheduled Hospitalization for the management of UA, occurring within 24 hours of the most
recent symptoms. Hospitalization is defined as an admission to an inpatient unit or a visit to an
ED that results in at least a 24 hours stay (or a change in calendar date if the hospital admission
or discharge times are not available).
This classification requires that 4 separate criteria be met:
a. Worsening Ischemic discomfort
b. Unscheduled Hospitalization
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c. Objective evidence of myocardial ischemia
d. Negative cardiac biomarkers
Note:
1. Escalation of pharmacotherapy for ischemia, while considered supportive evidence, is
not sufficient to qualify as UA hospitalization without objective evidence of ischemia.
2. Admission for suspected UA does not qualify as a UA hospitalization if a noncardiac or
nonischemic etiology is subsequently identified.
3. An ischemic event meeting the criteria for acute MI is not a UA hospitalization.
4. Planned hospitalization or re-hospitalization for performance of an elective
revascularization (e.g., positive stress test, staged revascularization) is not a UA
hospitalization.
5. Hospitalization with revascularization of CAD identified during elective cardiac
catheterization does not qualify as a UA hospitalization.
UA Hospitalization Terminology Concept
UA Hospitalization Date-Time
Date and time of the presentation of the patient to the hospital for management of UA. Date
and time of registration in the ED (or hospital, if the patient is not seen in the ED).
UA Hospitalization-Symptoms of Ischemia
Documentation of ischemic discomfort (angina, or symptoms thought to be equivalent) >10 min
in duration occurring either a) at rest, or b) in an accelerating pattern with frequent episodes
associated with progressively decreasing exercise capacity.
UA Hospitalization-Evidence of Ischemia
Documentation of objective evidence of new or worsening coronary ischemia.
Changes on resting ECG: New or worsening ST or T wave changes on resting ECG (in the
absence of confounders such as LBBB or LVH), defined as either a) Transient ST elevation
(duration <20 minutes): new ST elevation at the J point ≥0.1 mV in 2 contiguous leads (other
than leads V2-V3); in leads V2-V3, the following cut-points apply: ≥0.2 mV in men ≥40 years,
≥0.25 mV in men <40 years or ≥0.15 mV in women; b) ST depression and T wave changes: new
horizontal or down-sloping ST depression ≥0.05 mV in 2 contiguous leads; and/or new
T inversion ≥0.3 mV in 2 contiguous leads with prominent R wave or R/S ration >1.
Inducible Myocardial Ischemia: Definite evidence of inducible myocardial ischemia believed to
be responsible for the myocardial ischemic symptoms/signs demonstrated by any of the
following:
• An early positive exercise stress test result, defined as ST elevation or >2 mm ST
depression before 5 METS
• Stress echocardiography (reversible wall motion abnormality)
• Myocardial scintigraphy (reversible perfusion defect)
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• MRI (myocardial perfusion deficit under pharmacologic stress).
Coronary Lesion on Angiography: Angiographic evidence of new or worsening lesion ≥70%
lesion (≥50% for the left main coronary lesion) and/or thrombus in an epicardial coronary artery
believed to be responsible for the myocardial ischemic symptoms/signs.
Coronary revascularization: Need for coronary revascularization procedure (PCI or CABG) for
the presumed culprit lesion(s). This criterion would be fulfilled if revascularization was
undertaken during the unscheduled hospitalization, or subsequent to transfer to another
institution without interceding home discharge.
UA Hospitalization- MI Excluded
Exclusion of the diagnosis of MI as the reason for hospitalization, including negative cardiac
biomarkers and no other evidence of acute MI.
5. Coronary Revascularization

Percutaneous Coronary Intervention

PCI is the placement of an angioplasty guidewire, balloon, or other device (e.g., stent,
atherectomy, brachytherapy, or thrombectomy catheter) into a native coronary artery or CABG
for the purpose of mechanical coronary revascularization. The assessment of coronary lesion
severity by intravascular ultrasonography, coronary flow reserve, or fractional flow reserve is
not considered a PCI procedure.
PCI Status
Elective: A procedure that can be performed on an outpatient basis or during a subsequent
hospitalization without significant risk of MI or death. For stable inpatients, a PCI procedure
that is performed during the hospitalization for convenience and ease of scheduling and not
because the patient’s clinical situation demands that the procedure be performed before
discharge.
Urgent: A procedure that should be performed on an inpatient basis and before discharge
because of significant concerns about the risk of myocardial ischemia, MI, and/or death.
Patients who are outpatients or in the ED at the time that the cardiac catheterization is
requested would warrant hospital admission based on clinical presentation.
Emergency: A procedure that should be performed as soon as possible because of
substantial concerns that ongoing myocardial ischemia and/or MI could lead to death. “As
soon as possible” refers to a patient whose condition is sufficiently acute that the provider
would 1) cancel a scheduled case to perform the procedure immediately in the next
available room during business hours or 2) would activate the on-call team if there were to
occur during the off hours.
Salvage: A procedure that is a last resort. The patient is in cardiogenic shock when the PCI
begins (i.e., the time at which the first guidewire or intracoronary device is introduced into
a coronary artery or bypass graft for the purpose of mechanical revascularization) or within
the last 10 minutes before the start of the case; or during the diagnostic portion of the case,
the patient received chest compressions or was on unanticipated circulatory support (e.g.,
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intra-aortic balloon pump, extracorporeal membrane oxygenation, or cardiopulmonary
support).
PCI Terminology Concept
PCI Procedure Success: Achievement of <30% residual diameter stenosis of all treated
lesions as assessed by visual inspection or QCA, without an in-hospital major adverse
cardiac event (death, MI, or repeat coronary revascularization of the target lesion).
Note: For some device interventions (e.g., balloon angioplasty), achievement of <50%
diameter stenosis by visual inspection or QCA is an acceptable definition for procedure
success.
PCI Target Lesion Segment: Name of the coronary artery segment where the PCI was
performed that is the subject of clinical investigation. In the context of clinical investigation,
any lesion treated or for which treatment was attempted with a device or technique being
studied. The length of the target lesion is inclusive of the arterial section treated with the
study device (e.g., a stent) and the 5mm proximal and 5mm distal to the treated section.
PCI Target Lesion Procedure Success: Achievement of <30% residual diameter stenosis of
the target lesion as assessed by visual inspection of QCA, without an in-hospital major
adverse cardiac event (death, MI, or repeat coronary revascularization of the target lesion).
For some device interventions (e.g., balloon angioplasty), achievement of <50% diameter
stenosis by visual inspection or QCA is an acceptable definition for technical angiographic
procedure success.
PCI-Abrupt Closure: New intraprocedural severely reduced flow (TIMI Grade 0-1) within the
target vessel that persists and requires intervention by stenting or other treatment or
results in MI or death. Abrupt closure requires an association with a vascular dissection,
thrombus, or severe spasm at the treatment site or within the instrumented vessel.
PCI-Dissection: New appearance of contrast and/or radiolucencies during PCI inconsistent
with the expected luminal dimensions of a lesion and/or vessel.
Coronary Artery Dissection Grade
Grade A: Minor radiolucencies with the lumen during contrast injection with no
persistence after dye clearance.
Grade B: Parallel tracts or double lumen separated by a radiolucent area during contrast
injection with no persistence after dye clearance.
Grade C: Extraluminal cap with persistence of contrast after dye clearance from the
lumen.
Grade D: Spiral luminal filling defect with delayed but complete distal flow.
Grade E: New persistent filling defect with delayed antegrade flow. May represent
thrombus.
Grade F: Non-A-E types with total coronary occlusion and no distal antegrade flow. May
represent thrombus.
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PCI-No Reflow: New acute reduction in coronary flow (TIME Grade 0-1) in the absence of
dissection, thrombus spasm, or high-grade residual stenosis at the original PCI lesion site.
PCI-Coronary Thrombosis: New acute development of compromise of a PCI vessel by
coronary artery thrombus (blood clot) occurring at any time during a procedure and
independent of evidence of stenosis or dissection. Criteria for an intraprocedural
thrombosis event include >1 of the following: a) Development of new or increasing
coronary thrombus; b) Abrupt vessel closure; c) No reflow (from TIMI flow 3/2 to 1/0) or
slow reflow (from TIMI 3 to 2); d) Distal embolization.
PCI-Intraprocedural Stent Thrombosis: Occlusion of the lumen of a newly implanted stent
by thrombus (blood clot) during the index stent implantation procedure.
PCI Stent Thrombosis: Compromise of the lumen of a coronary stent by thrombus (blood
clot) and not as a result of restenosis or atherosclerosis after completion of the stent
implantation procedure.
Note: Angiographic nonocclusive intracoronary thrombus is defined as a (spheric, ovoid, or
irregular) noncalcified filling defect or lucency surrounded by contrast material (on 3 sides)
or within a coronary stenosis) seen in multiple projections, or persistence of contrast
material within the lumen, or a visible embolization of intraluminal material downstream.
Angiographic occlusive thrombus is defined as the presence of TIMI 0 or TIMI 1 flow
intrastent or proximal to a stent up to the most adjacent proximal side branch or main
branch (if it originates from the side branch). Pathological confirmation of stent thrombosis
is evidence of recent thrombosis within the stent determined at autopsy or by examination
of tissue retrieved following thrombectomy.
PCI Stent Thrombosis Date-Time: Date and time of the onset of stent thrombosis.
PCI Stent Thrombosis ARC Grade: Probability that coronary artery stent thrombosis has
occurred, according to ARC grading criteria.
Note: The incidental angiographic documentation of stent occlusion in the absence of
clinical signs or symptoms is not considered a confirmed stent thrombosis (silent occlusion).
Definite: Definite stent thrombosis is considered to have occurred when there is either
angiographic or pathological confirmation. Angiographic confirmation is the presence of
a thrombus at coronary angiography that originates in the stent or in the segment 5 mm
proximal or distal to the stent, with the presence of at least 1 of 3 clinical criteria within
a 48 hour time window: a) Acute onset of ischemic symptoms at rest; b) New ischemic
changes on ECG that suggest acute ischemia; c) Typical rise and fall in cardiac
biomarkers.
Probable: Probable stent thrombosis is considered to have occurred after intracoronary
stenting in the following situations: a) Any unexplained death within the first 30 days
(for studies of patients with an ST-segment elevation MI, exclusion of unexplained death
within 30 days as evidence of probable stent thrombosis); b) irrespective of the time
after the index procedure, any MI that is related to documented acute ischemia in the
territory of the implanted stent and without angiographic confirmation of stent
thrombosis and in the absence of any other obvious cause.
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Possible: Possible stent thrombosis is considered to have occurred with any unexplained
death >30 days after intracoronary stenting.
PCI Stent Thrombosis ARC Timing: Timing of the detection of stent thrombosis according to
the ARC grading criteria, with time 0 defined as the time when the patient departs the
catheterization laboratory after a stent implantation procedure.
Note: The combination of acute or subacute stent thrombosis can be replaced by the term
early stent thrombosis (0-30 days).
Acute: 0-24 h after stent implantation
Subacute: >24 hours to 30 days after stent implantation
Late: >30 days to 1 year after stent implantation
Very Late: >1 year after stent implantation
PCI Stent Restenosis: Renarrowing of a stent implanted at a lesion site to treat a prior
stenosis, to a diameter stenosis of >50% within the stent, inclusive of the original treated
site plus the adjacent vascular segments 5 mm proximal and 5 mm distal to the stent.
PCI Lesion Restenosis: Renarrowing of a lesion site following treatment of a prior stenosis,
to a diameter stenosis of >50% at the previous treated lesion site, plus the adjacent vascular
segments 5 mm proximal and 5 mm distal to the treated segment.
PCI-TLR: Repeat percutaneous intervention of a target lesion, or surgical bypass of a target
vessel, performed for restenosis or other complication involving the target lesion. The
length of the target lesion is inclusive of the treated section and the 5 mm proximal and
distal to the treated section. In the assessment of TLR, angiograms should be assessed by an
angiographic core laboratory (if designated) and made available to the CEC for review on
request.
PCI Ischemia before TLR: Criteria for clinical or functional ischemia include any of the
following: a) History of angina pectoris, presumably related to the target vessel;
b) Objective signs of ischemia at rest (electrocardiographic changes) or during exercise test
(or equivalent), presumably related to target vessel; c) abnormal results of any invasive
functional diagnostic test (e.g., CFR or FFR).
PCI-Clinically Driven TLR: PCI TLR is clinically driven if the target lesion diameter stenosis is
>50% by QCA and the subject has clinical or functional ischemia that cannot be explained by
another native coronary or bypass graft lesion. TLR of a >70% diameter stenosis by QCA in
the absence of the above signs or symptoms may be considered clinically driven. In the
absence of QCA data or if a stenosis <50% is present, TLR may considered clinically driven if
the severe ischemic signs and symptoms attributed to the target lesion are present.
PCI-TLF (target lesion failure): The composite of ischemia-driven target lesion
revascularization, MI related to the target vessel, or cardiac death related to the target
vessel. If it cannot be determined with certainty whether an MI or death was related to the
target vessel, it is considered a TLF.
PCI Target Vessel: In the context of clinical investigation, the major native coronary artery
(e.g., left main coronary artery, LAD coronary artery, left circumflex coronary artery, or right
 71
coronary artery) or bypass graft containing the target lesion. A native coronary artery target
vessel includes the arterial segments upstream and downstream from the target lesion plus
major side branches.
Left Main Artery: Left Main Coronary Artery
LAD Artery: LAD coronary artery, including septal and diagonal branches
Left Circumflex Artery: Left circumflex coronary Artery, including marginal branches; if
mixed dominance, also including left posterolateral branches; if left dominant, also
including posterolateral and posterior descending branches.
Ramus Intermedius Artery: Ramus intermedius coronary branch
Right Coronary Artery: Right coronary artery and its branches; if mixed dominance, also
including posterior descending branch; if right dominant, also including right
posterolateral and posterior descending branches.
PCI-TVR: Repeat PCI or surgical bypass of any segment of a coronary artery containing a
target lesion. A target vessel is defined as the entire major coronary vessel proximal and
distal to a target lesion, including upstream and downstream branches and the target lesion
itself. In the assessment of TVR, angiograms should be assessed by an angiographic core
laboratory (if designated) and made available to the CEC for review on request.
PCI-TVF: The composite of ischemia-driven TVR, MI related to the target vessel, or cardiac
death related to the target vessel. If it cannot be determined with certainty whether the MI
or death was related to the target vessel, it is considered a TVF.
PCI-Nontarget Lesion Segment: Name of a coronary artery segment where PCI was
performed that is NOT the subject of clinical investigation. In the context of clinical
investigation, any lesion not treated or for which no attempt at treatment was made with
the device or technique being studied. This includes lesions treated with (nonstudy) PCI and
lesions managed medically.
PCI-Nontarget Lesion Revascularization: Any (de novo or repeat) PCI of a nontarget lesion
or surgical bypass of a nontarget vessel. This includes revascularization at the time of an
index (study) PCI of a separate target lesion and subsequent revascularization after the
index (study) PCI.
PCI-Nontarget Vessel: In the context of clinical investigation, any major native coronary
artery (e.g., left main coronary, LAD coronary artery, left circumflex coronary artery, or right
coronary artery) or bypass graft treated or for which no attempt at treatment was made
with a device or technique being studied. This includes vessels treated with (nonstudy) PCI
and vessels managed medically.
PCI-Nontarget Vessel Revascularization: Any (de novo or repeat) PCI or surgical bypass of
any segment of a nontarget vessel. This includes revascularization at the time of an index
(study) PCI of a separate target lesion and subsequent revascularization after the index
(study) PCI.
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Coronary Angiography TIMI Flow Grade: Grading scale to describe coronary epicardial
blood flow as visualized during angiography according to the classification described by the
TIMI group.
TIMI FLOW GRADE
Grade 0: No perfusion. There is no antegrade flow beyond the point of occlusion.
Grade 1: Penetration without perfusion. Contrast material passes beyond the area of
obstruction but “hangs up” and fails to opacify the entire coronary bed distal to the
obstruction for the duration of the cineangiographic filming sequence.
Grade 2: Partial perfusion. The contrast material passes across the obstruction and
opacifies the coronary bed distal to the obstruction. However, the rate of entry of
contrast material into the vessel distal to the obstruction or its rate of clearance from
the distal bed (or both) is perceptibly slower than its entry into or clearance from
comparable areas not perfused by the previously occluded vessel (e.g., the opposite
coronary artery or the coronary bed proximal to the obstruction).
Grade 3: Complete perfusion. Antegrade flow into the bed distal to the obstruction
occurs as promptly as into the bed proximal to the obstruction, and clearance of
contrast material from the involved bed is as rapid as from an uninvolved bed in the
same vessel or the opposite artery.
Coronary Angiography-Coronary Artery Thrombus: A discrete, mobile, intraluminal filling
defect with defined borders with or without associated contrast staining.
Coronary Angiography-TIMI Thrombus Grade: Grading scale to describe coronary
thrombus as visualized during angiography per the classification described by the TIMI
group.
TIMI CORONARY THROMBUS GRADE
Grade 1: Possible thrombus present: angiography demonstrates characteristics such as
reduced contrast density, haziness, irregular lesion contour, or a smooth convex
“meniscus” at the site of total occlusion suggestive, but not diagnostic, of thrombus.
Grade 2: Small definite thrombus, with the greatest dimension less than or equal to one-
half of the vessel diameter.
Grade 3: Moderate definite thrombus, with the greatest linear dimension greater than
one-half but <2 vessel diameters.
Grade 4: Large definite thrombus, with the greatest dimension ≥2 vessel diameters.
Grade 5: Total vessel occlusion.
Cardiovascular Catheterization-Access Site Hematoma: Development of a new, localized
collection of blood at a vascular access site sufficient to produce a palpable mass within
72 hours of a procedure.
Cardiovascular Catheterization-Arteriovenous Fistula: Development of a new, unintended
communication between an artery and a vein occurring at a vascular access site within
72 hours of a procedure.
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Cardiovascular Catheterization-Peripheral Ischemia: Development of new arterial
insufficiency sufficient to produce clinical signs or symptoms of ischemia (pallor, pain,
paresthesia) distal to a vascular access site within 72 hours of a procedure.
Cardiovascular Catheterization-Peripheral Nerve Injury: Development of new sensory or
motor loss of peripheral nerve function from external nerve compression (e.g., as a result of
positioning during a procedure), or internal compression or direct nerve damage from the
procedure, occurring within 72 hours of a procedure.
Cardiovascular Catheterization-Pseudoaneurysm: Development of a new localized
collection of blood with a persistent communication (neck) originating at a vascular access
site and occurring within 72 hours of a procedure.
Cardiovascular Catheterization-Retroperitoneal Hemorrhage: Development of new
bleeding into the retroperitoneal space originating at a vascular access site and occurring
within 72 hours of a procedure.

Coronary Artery Bypass Grafting

CABG: CABG surgery is a procedure performed to bypass partially or completely occluded
coronary arteries with veins and/or arteries harvested from elsewhere in the body, thereby
improving the blood supply to the coronary circulation supplying the myocardium (heart
muscle).
CABG Status: Classification of the urgency of a CABG surgical procedure, based on the
patient’s clinical status before entering the operating room.
Elective: Patient cardiac status has been stable in the days or weeks before the
operation. The procedure can be deferred without increased risk of compromised
cardiac outcome.
Urgent: Procedure required during the same hospitalization to minimize chances of
clinical deterioration or adverse outcome. Clinical conditions include (but are not limited
to) acute or worsening chest pain, acute or worsening HF, acute MI, critical coronary
stenosis, IABP support, UA with intravenous nitroglycerin, and rest angina.
Emergency: Procedure required because of ongoing, refractory (difficult, complicated,
and/or unmanageable), unrelenting cardiac compromise, with or without hemodynamic
instability, and not responsive to any form of therapy except cardiac surgery. An
emergency operation is one in which there should be no delay in providing operative
intervention. The clinical status of the patient can include any of the following:
a. Ischemic dysfunction (any of the following): 1) ongoing ischemia, including rest
angina despite maximal medical therapy (medical and/or IABP); 2) acute evolving MI
within 24 hours before surgery; or 3) pulmonary edema requiring intubation.
b. Mechanical dysfunction (either of the following): 1) shock with circulatory support or
2) shock without circulatory support.
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Salvage: The patient is undergoing CPR or is being managed with extracorporeal
membrane oxygenation en route to the operating room or before induction of
anesthesia. The clinical acuity of the patient is a dying state.
Cardiothoracic Surgery-Inoperable/Extreme Risk: Heart Team assessment that a patient is
inappropriate for cardiothoracic surgery, based on predicted operative mortality,
comorbidities, frailty/debilitation, previous procedures, technical inoperability, and/or
other extenuating circumstances.
CABG Type: Type of CABG conduit.
Saphenous Vein Graft: CABG composed of saphenous vein.
Arterial Graft, in situ: CABG composed of arterial conduit, where the origin of the graft
remains intact.
Arterial Graft, free: CABG composed of an artery that has been completely freed from
its original location.
PCI-Bypass Graft Lesion: Location of a lesion within a CABG where PCI was performed.
Graft Origin: The section of a graft from the connection (anastomosis) of the graft with
the aorta (or from the origin if in situ), inclusive of the first 3 mm of the graft.
Graft Body: The section of a graft between the origin and the anastomosis.
Graft Anastomosis: The section of a graft from the connection (anastomosis) of the graft
with the coronary artery, inclusive of the retrograde 3 mm of the graft.
CABG-Anastomosis: The coronary artery segment to which a CABG is connected.

Definitions of New Onset Type 2 Diabetes Mellitus

Definition for Post-Randomization New Onset Type 2 Diabetes Mellitus

New-onset type 2 diabetes mellitus defined by one or more of the following criteria according
to the current American Diabetes Association (ADA)2 guidelines:
1. Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric
intake for at least 8 hours;* or
2. Two-hour post-prandial glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose
tolerance test as defined in the ADA guidelines;* or
3. HbA1C measurement ≥6.5% (48 mmol/mol);* or
4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a
random plasma glucose ≥200 mg/dL (11.1 mmol/L).
*Notes: In the absence of unequivocal hyperglycemia, diagnosis requires 2 abnormal
test results from the same sample or in the 2 separate test results.
Reference: American Diabetes Association, Diagnosis and Classification of
Diabetes Mellitus. Diabetes Care. 2014;37(Supplement 1):S81-90
 75
Additionally, new-onset type 2 diabetes mellitus may also be defined by one positive laboratory
test that fulfills the ADA criteria and is accompanied by Principal Investigator (PI) and/or
Primary Care Physician (PCP) documentation that may include doctor’s notes, letters, memos,
emails, or hospital records that support a diagnosis based on documented symptoms of
unequivocal hyperglycemia. A list of symptoms is provided below:

Unequivocal Hyperglycemia Symptoms

• Hyperglycemic crisis
OR
• Classic symptoms of hyperglycemia including:
- increased thirst and/or hunger
- blurred vision
- frequent urination
- headache
- fatigue
- weight loss
- vaginal/skin infections
- slow healing cuts/sores
- vomiting
- dehydration
- unusual fruity smell on breath
- hyperventilation
- rapid heartbeat
- confusion
- coma
Note: Use of a glucose lowering medication in the absence of supporting laboratories (central
and/or local), adverse events, and/or Principal Investigator (PI) and/or Primary Care Physician
(PCP) documentation does not support verification of new T2DM as defined by the ADA criteria.

Definitions of Tendon Rupture

Should be confirmed by diagnostic finding or

Have at least 1 symptom and 1 PE finding that are consistent with the rupture type, when
diagnostics were not completed or results are not available. A rupture could be a complete or
partial tear.

Symptoms consistent with the tear or rupture for the affected area may include

• Snap/pop
• Pain in the affected area consistent with a tear or rupture
• Shoulder pain during sleep
• Weakness of affected area consistent with a tear or rupture
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• Inability to use/move affected limb
• Inability to bear weight
• Other
Physical Exam consistent with tear or rupture for the affected area

• Deformity
• Swelling of the affected area
• Gap felt in the tendon
• Bruising of the affected area
• Unable to extend the affected extremity completely
• Unable to reach arm in front of self about the shoulder level
• Unable to support self on tiptoes on the affected limb
• Decreased strength of elbow flexion
• Decreased ability to raise the arm out to the side when the hand is turned palm up.
• Positive Simmonds-Thompson Test (Achilles rupture)
• Other
Diagnostic findings consistent with a tear or rupture for the affected area

• X-RAY
• MRI
• CT
• Ultrasound
Surgery
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Representativeness of Study Participants
Category CLEAR OUTCOMES
Patients with or at risk for cardiovascular disease who have an inability to maximize or tolerate statins
Disease, problem, or condition under
(partial or complete statin intolerance). The primary prevention population was capped at 30% of the
investigation
overall study population.
Special considerations related to:

Men generally develop CVD at a younger age and have a higher propensity of developing CHD than women.
Women in contrast are at a higher risk of stroke. Mortality from CHD and stroke remains higher among men
Sex and gender than women until later in life. However, after adjusting for age and risk factors the relationship is close to
1:1. Non-adherence with statins is greater in women than in men, and the primary reason for lack of statin
adherence is complete or partial statin intolerability.
Age Prevalence of CVD increases dramatically with age; women with CVD are generally older than men with CVD

CVD disproportionately affects racial and ethnic minorities. For example, CVD is diagnosed in higher
numbers in Black adults compared to White adults. Similarly, some risk factors for CVD are higher in
minority groups. For example, there is a higher prevalence of diabetes mellitus in both Hispanic and
American Indian populations compared with White populations. In addition, statin intolerance is known to
Race or ethnic group
disproportionately effect Asians, Asian Indians, Hispanics and Black populations – all groups are historically
underrepresented in clinical trials, especially in trials focused on CVD. Patients who have experienced statin
intolerability are often intentionally excluded from cardiovascular clinical studies, limiting the data
generated regarding women and cardiovascular disease, as well as statin intolerability more generally.

CVD is generally consistent across the globe after adjusting for age and risk factor distribution which differs
Geography by country and region. Third world countries no longer have the advantage they once had based on
increasing rates of CV risk factors.

Projected rates of CVD will increase significantly by the year 2060. Notably, CVD rate increases are projected
Other considerations to have the highest impact on Black and Hispanic populations while projections for White persons gradually
decreased. Prevalence of cardiovascular risk factors and diseases will continue to rise despite global efforts.

The participants in the present trial demonstrated the expected ratio of men to women. It is to be noted
that this is the first lipid lowering outcomes study to include a representative distribution of men and
women other than the PROSPER trial of older adults. Biologic sex was reported by the participants; on the
Overall representativeness of this trial
intake survey, they were asked, “What was your sex assigned at birth?” Options were female or male. There
were no specific questions on gender. The age distribution in the study population is consistent with
distribution for CVD and accumulation of risk factors for CVD. The proportion of Black patients who
 78
underwent randomization overall was small (2.3%); among patients enrolled in North America, the percent
of Black patients was higher at 6.3% but was still underrepresented of the Black population in the United
States. Asia patient participation was low at 1.9% overall and 0.8% of the North American enrolled patients.
This was due to no patients being enrolled in East Asia. No patient was enrolled in Africa. The proportion of
Hispanic patients who underwent randomization overall (16.7%) and in North America (17.6%) was similar
to the proportion of the Hispanic population in the US (18.9%).
 79
References
1. Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al; European
Atherosclerosis Society Consensus Panel. Statin-associated muscle symptoms: impact on statin
therapy-European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology
and Management. Eur Heart J. 2015;36(17):1012-22.
2. American Diabetes Association, Diagnosis and Classification of Diabetes Mellitus. Diabetes Care.
2014;37(Supplement 1):S81-90.