Open-label, Randomized Trial in Participants Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

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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