CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 803 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.

Search/NCT01651780
NCT01651780Phase 3Completed
CompareCT.gov

Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)

The Medicines Company·interventional·Posted Jul 27, 2012·Updated Apr 7, 2017

In Brief

A Phase 3 clinical trial evaluating Bivalirudin and Unfractionated Heparin for Severe Aortic Stenosis and 2 related conditions. Completed, enrolled 803 participants across 33 sites in 7 countries.

Detailed Summary

The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Aortic Stenosis, Transcatheter Aortic Valve Replacement, Aortic Valve Replacement
CountriesCanada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2012
Enrollment StartOct 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.9 years ago

Interventions

Bivalirudindrug

Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.

Unfractionated Heparindrug

Unfractionated heparin is an anticoagulant.