At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,198 enrolled
Drug / intervention
Bivalirudin +1 moredrug
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.
Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin)
In Brief
A Phase 3 clinical trial evaluating Bivalirudin and Heparin for Acute Coronary Syndrome. Completed, enrolled 2,198 participants across 145 sites in 9 countries.
Detailed Summary
To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in participants with ST segment elevation acute coronary syndrome (STE-ACS), intended for a primary percutaneous coronary intervention (PCI) management strategy, presenting either via ambulance or to centers where PCI is not performed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesAustria, Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Slovenia
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionAug 2013
Study CompletionAug 2014
TodayJul 2026
First PostedMar 16, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.3 years ago
Interventions
Bivalirudindrug
Heparindrug