CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Angiomax (bivalirudin) anticoagulantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00093158
NCT00093158Phase 3Completed

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 Medicines Company·interventional·Posted Oct 7, 2004·Updated Aug 21, 2007

In Brief

A Phase 3 clinical trial evaluating Angiomax (bivalirudin) anticoagulant for Unstable Angina and 2 related conditions. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 7, 2004
Enrollment StartAug 1, 2003
Study CompletionJan 1, 2007
TodayJul 2, 2026
Posted 21.7 years ago

Interventions

Angiomax (bivalirudin) anticoagulantdrug