CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,721 enrolled
Drug / intervention
Abciximab + UFH +2 moredrug
Likely dose
Abciximab + UFH 0.25 mg/kgfrom 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/NCT00373451
NCT00373451Phase 4Completed

Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions (ISAR-REACT-4)

Deutsches Herzzentrum Muenchen·interventional·Posted Sep 8, 2006·Updated May 8, 2012

In Brief

A Phase 4 clinical trial evaluating Abciximab + UFH, Bivalirudin, and 1 other intervention for Myocardial Infarction and Coronary Disease. Completed, enrolled 1,721 participants across 9 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine which of these anti-clotting medications, abciximab plus unfractionated heparin or bivalirudin, is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing coronary intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Italy
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2006
Enrollment StartJul 1, 2006
Primary CompletionMay 1, 2011
Study CompletionJul 1, 2011
TodayJul 1, 2026
Enrollment to primary: 4.8 yearsPosted 19.8 years ago

Interventions

Abciximab + UFHdrug

Abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125 µg/kg/minute \[maximum of 10 µg/minute\] infusion for 12 hours)

Bivalirudindrug

Bivalirudin (intravenous bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure)

Heparindrug

i.v. bolus of 70 units/kg/body weight of unfractionated heparin