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A Phase: Ggrastat
A Phase: Ggrastat
of the
AGGRASTAT to ZOCOR (A to Z) Trial
Comparison of the safety and efficacy of unfractionated heparin versus
enoxaparin in combination with tirofiban and aspirin in individuals who
present with non-ST elevation acute coronary syndromes
Background
Enoxaparin (ENOX) has demonstrated superiority to unfractionated
heparin (UFH) in ACS populations managed conservatively in the
absence of GP IIb/IIIa inhibitors (TIMI 11, ESSENCE)
GP IIb/IIIa inhibitors are now recommended for high risk ACS patients in
whom an invasive strategy is planned
Trials suggest additional benefit of a low molecular weight heparin
(LMWH) over UFH when used in combination with GP IIb/IIIa inhibitors
(INTERACT)
The goal of the A Phase of A to Z was to compare the safety and efficacy
of enoxaparin (ENOX) vs unfractionated heparin (UFH) in combination
with tirofiban and aspirin in the management of NSTEMI-ACS
9.4
10
8.4
Incidence (%)
Non-inferiority = upper
bound of one-sided
95% CI < 1.144
Upper BoundOne-Sided
95% CI in A to Z: 1.05,
p=NS
2
Non-inferiority criteria
met
Enox
www. Clinical trial results.org
UFH
Presented at ACC 2003 Late Breaking Clinical Trials
Conclusions:
A to Z met its primary hypothesis: Among pts with
NSTEMI ACS treated with tirofiban and ASA,
Enoxaparin is non-inferior to UFH for the composite
of Death, MI and Refractory Ischemia
Based on the data from TIMI 11, ESSENCE,
INTERACT and A to Z, enoxaparin is an attractive
alternative to heparin when used in combination with
tirofiban and ASA
SYNERGY will further address the efficacy of
enoxaparin among patients treated with an early
invasive strategy
www. Clinical trial results.org