NCT00093158

Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes (ACS)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13,800 (planned)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unstable Angina
• Myocardial Infarction
• Acute Disease

Interventions

Type	Name	Description
DRUG	Angiomax (bivalirudin) anticoagulant

Timeline

• Start date: 2003-08-01
• Completion: 2007-01-01
• First posted: 2004-10-07
• Last updated: 2007-08-21

Locations

1 site across 1 country: United States