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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01651780
Other study ID # Protocol No. TMC-BIV-11-02
Secondary ID 2012-000632-26
Status Completed
Phase Phase 3
First received July 24, 2012
Last updated October 27, 2015
Start date October 2012
Est. completion date August 2015

Study information

Verified date October 2015
Source The Medicines Company
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)United Kingdom: Medicines and Healthcare Products Regulatory AgencySwitzerland: EthikkommissionCanada: Ethics Review CommitteeItaly: The Italian Medicines AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Institute for Health ResearchSwitzerland: SwissmedicCanada: Health CanadaGermany: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Description:

This study will be an international, multi-center, open-label, randomized controlled trial in patients undergoing TAVR. Following the conclusion of the roll-in phase of 2 patients per site, who will comprise the feasibility cohort of approximately 70 patients, 550 patients will be randomized to bivalirudin or UFH at approximately 35 centers. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Trans-Aortic Valve Replacement
transcatheter aortic valve replacement (TAVR) procedures performed via the transfemoral approach

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
The Medicines Company

Countries where clinical trial is conducted

Canada,  France,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

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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