At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 4,570 enrolled
Drug / intervention
Bivalirudin +1 moredrug
Likely dose
Bivalirudin 0.75 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.
Prospective, Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Bivalirudin and Un-fractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions. ISAR-REACT-3
In Brief
A Phase 4 clinical trial evaluating Bivalirudin and Un-fractionated heparin for Coronary Disease and Angina Pectoris. Completed, enrolled 4,570 participants across 4 sites.
Detailed Summary
The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Disease, Angina Pectoris
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedDec 2005
Primary CompletionFeb 2008
Study CompletionMay 2008
TodayJul 2026
First PostedDec 6, 2005
Enrollment StartNov 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionMay 1, 2008
TodayJul 1, 2026
Enrollment to primary: 2.3 yearsPosted 20.6 years ago
Interventions
Bivalirudindrug
bivalirudin to be administered as an 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.
Un-fractionated heparindrug
UFH is given as an intravenous bolus of 140 units/kg followed by infusion of placebo 1.75 mg/kg per hour for the duration of the procedure.