Myocardial Infarction Clinical Trial
Official title:
The ACUITY Trial: A Randomized Comparison of Angiomax (Bivalirudin) Versus Heparin (Unfractionated Heparin or Enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndromes Without ST-Segment Elevation
The purpose of this study is to show that, when compared with heparin (enoxaparin or
unfractionated heparin) and routine GPIIb/IIIa inhibition (either started upfront or at the
time of percutaneous coronary intervention [PCI]; Arm A):
1. Bivalirudin with routine GPIIb/IIIa inhibition (either started upfront or at the time
of PCI; Arm B) provides non-inferior or superior overall clinical outcomes and
2. Bivalirudin alone (Arm C) reduces clinically significant bleeding. An important
secondary objective for this comparison is to show that bivalirudin is not inferior for
ischemic complications.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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