BRAVO 2/3
Research type
Research Study
Full title
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3
IRAS ID
107545
Contact name
David Hildick-Smith
Sponsor organisation
The Medicines Company
Eudract number
2012-000632-26
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate whether the use of bivalirudin (Angiox), as a procedural anticoagulant during a transcatheter aortic valve replacement (TAVR) procedure, will reduce the procedural complications compared to unfractionated heparin (heparin) which is the current standard treatment.This is an international, multicenter, open-label, randomized controlled trial with a planned population of around 620 patients All patients undergoing TAVR performed through a large artery in the groin (transfemoral approach) at the participating centres will be eligible.The investigator or treating physician will ask patientsselected for a TAVR procedure if they are interested to participate in the BRAVO 2/3 study, will provide them with a patient information'sheet and will ask them for their consent before starting the study. The first two patients to qualify for this study at each site will be enrolled into the bivalirudin group. Thereafter patients will be randomly (by chance, like flipping a coin) placed into one of two treatment groups. For patientsplaced in the bivalirudin group, they will first receive a bivalirudin bolus (preferably into the valve sheath) and an infusion thereafter during the TAVR procedure. patients will receive other medications to prevent complications related to the procedure based on the physician's judgment. For patientsplaced in the heparin group, heparin will be given by intravenous injection (into the vein) during the TAVR procedure. These medications will continue during the procedure, and after the procedure if required. There is an equal chance of being allocated one of these two treatments.patients will undergo TAVR according to current standard of care practices including use of antiplatelet agents (medications used to prevent platelets sticking to each other and to the inside of blood vessels, and reduce the risk of thrombosis) before, during, and after procedure and possibly oral anticoagulan's post procedure.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
12/SW/0378
Date of REC Opinion
22 Mar 2013
REC opinion
Further Information Favourable Opinion