Aortic Valve Insufficiency Clinical Trial
— BRAVO-2/3Official title:
Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)
This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively
Status | Completed |
Enrollment | 868 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - = 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 [GFR<30 ml/min] since these patients 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 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 (e.g. requiring inotropic or IABP 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 LMWHs within 24 hours of the procedure - Dabigatran, rivaroxaban or other oral anti-Xa or antithrombin agent within 48 hours of the procedure - Thrombolytics, GPI, 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 enrolment 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 Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montreal | Quebec |
Canada | St. Paul´s Hospital Providence Health Care | Vancouver | |
France | CHU Jean Minjoz, Service de Cardiologie | Besançon | |
France | Centre Hospitalier de Lyon | Bron | |
France | Department of Cardiology, CHRU Lille | Lille | |
France | Institut Hospitalier Jacques Cartier | Massy | |
France | Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle | Rouen | |
France | CHU de Toulouse | Toulouse | Cedex 9 |
France | Clinique Pasteur, Unité de Cardiologie Interventionnelle | Toulouse | Cedex 3 |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Klinikum links der Weser Bremen | Bremen | |
Germany | Elisabeth-Krankenhaus Essen | Essen | |
Germany | Freiburg University | Freiburg | |
Germany | Asklepios St. Georg Hamburg | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | University Heart Centre, Clinic of Inner Medicine 1 Cardiology | Jena | Lobeda Ost |
Germany | Universität Leipzig - Herzzentrum GmbH | Leipzig | |
Germany | Universitätsmedizin der Johannes Gutenberg-Universitat Mainz | Mainz | |
Germany | Deutsches Herzzentrum München | München | |
Germany | LMU Munich, Klinikum der Universität München | Munich | |
Germany | Helios Heart Center Siegburg | Siegburg | |
Italy | Ferraroto Hospital, University of Catania | Catania | |
Italy | Ospedale San Raffaele U.O. Cardiologia Interventistica | Milano | |
Italy | Azienda Ospedaliero-Universitaria Pisana | Pisa | |
Italy | Azienda Ospedaliera San Camillo-Forlanini | Roma | |
Italy | Policlinico Umberto I, Università La Sapienza | Roma | |
Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
Netherlands | University Medical Center Utrecht | Utrecht | |
Switzerland | Cardiology University Hospital Basel | Basel | |
Switzerland | Universitätsklinik Bern | Bern | |
United Kingdom | The Royal Sussex County Hospital | Brighton | East Sussex |
United Kingdom | Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
The Medicines Company |
Canada, France, Germany, Italy, Netherlands, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Bleeding | The primary end point will be major bleeding defined as Bleeding Academic Research Consortium (BARC) type =3b at 48 hours or hospital discharge whichever occurs first. | 48 hours post-procedure or discharge | Yes |
Secondary | Bleeding | The secondary endpoints of this trial are: (1) Major bleeding according to additional scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS); (2) Bleeding BARC =3; moderate bleeding BARC = 3a; minor bleeding (BARC type 1 and 2 and TIMI minor); (3) major adverse cardiac events (MACE) including death, non-fatal MI, and stroke; (4) the rates of the individual components of MACE; (5) transient ischemic attack; (6) acute kidney injury; (7) VARC major vascular complications; (8) acquired thrombocytopenia; (9) rate of new post-procedural atrial fibrillation/flutter; and (10) economic analysis of using bivalirudin in TAVR. | 48 hours post-procedure or discharge | Yes |
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