Trials / Completed
CompletedNCT01651780
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 803 (actual)
- Sponsor
- The Medicines Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bivalirudin | Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion. |
| DRUG | Unfractionated Heparin | Unfractionated heparin is an anticoagulant. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2012-07-27
- Last updated
- 2017-04-07
- Results posted
- 2017-02-27
Locations
33 sites across 7 countries: Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01651780. Inclusion in this directory is not an endorsement.