Brief Title
Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH
Official Title
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
Brief 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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
Secondary Outcome
NACE at 48 Hours or Before Hospital Discharge
Condition
Severe Aortic Stenosis
Intervention
Bivalirudin
Study Arms / Comparison Groups
Bivalirudin
Description: Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
803
Start Date
October 2012
Completion Date
June 2015
Primary Completion Date
June 2015
Eligibility Criteria
Inclusion Criteria: - Males and females, ≥18 years of age - High risk (Euroscore ≥18, or considered inoperable) for surgical aortic valve replacement - Undergoing TAVR via transfemoral arterial access - Provide written informed consent before initiation of any study related procedures Exclusion Criteria: - Any known contra-indication to the use of bivalirudin (except presence of severe renal impairment [glomerular filtration rate (GFR) <30 milliliters (mL)/minute] since these participants will be included in the trial or UFH - Refusal to receive blood transfusion - Mechanical valve (any location) or mitral bioprosthetic valve - Extensive calcification of the common femoral artery, or minimal luminal diameter <6.5 millimeters (mm) - Use of elective surgical cut-down for transfemoral access - Concurrent performance of percutaneous coronary intervention with TAVR - International normalized ratio (INR) ≥2 on the day of TAVR procedure or known history of bleeding diathesis - History of hemorrhagic stroke, intracranial hemorrhage, intracerebral mass or aneurysm, or arteriovenous malformation - Severe left ventricular dysfunction (left ventricular ejection fraction <15%) - Severe aortic regurgitation or mitral regurgitation (4+) - Hemodynamic instability (for example, requiring inotropic or intra-aortic balloon pump support) within 2 hours of the procedure - Dialysis dependent - Administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, or warfarin in the 3 days prior to the procedure - Acute myocardial infarction, major surgery, or any therapeutic cardiac procedure (other than balloon aortic valvuloplasty) within 30 days - Percutaneous coronary intervention within 30 days - Upper gastrointestinal or genitourinary bleed within 30 days - Stroke or transient ischemic attack within 30 days - Any surgery or biopsy within 2 weeks - Administration of: - UFH within 30 minutes of the procedure - Enoxaparin within 8 hours of the procedure - Fondaparinux or other low-molecular-weight heparins (LMWHs) within 24 hours of the procedure - Dabigatran, rivaroxaban, or other oral anti-Xa or antithrombin agent within 48 hours of the procedure - Thrombolytics, glycoprotein IIb/IIIa inhibitor, or warfarin within 72 hours of the procedure - Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast - Contraindications or allergy to aspirin or clopidogrel - Known or suspected pregnant women or nursing mothers. Women of child-bearing potential will be asked if they are pregnant and will be tested for pregnancy - Previous enrollment in this study - Treatment with other investigational drugs or devices within the 30 days preceding enrollment or planned use of other investigational drugs or devices before the primary endpoint of this study has been reached
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thierry Lefevre, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01651780
Organization ID
TMC-BIV-11-02
Secondary IDs
2012-000632-26
Responsible Party
Sponsor
Study Sponsor
The Medicines Company
Study Sponsor
Thierry Lefevre, MD, Principal Investigator, Hôpital Privé Jacques Cartier
Verification Date
March 2017