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

NCT01651780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2017-04-07

Study results available
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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.

Conditions

  • Severe Aortic Stenosis
  • Transcatheter Aortic Valve Replacement
  • Aortic Valve Replacement

Interventions

DRUG

Bivalirudin

Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.

DRUG

Unfractionated Heparin

Unfractionated heparin is an anticoagulant.

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Thierry Lefevre, MD · Hôpital Privé Jacques Cartier

  • Eberhardt Grube, MD · University Hospital, Bonn

  • George D Dangas, MD, PhD · The Zena and Michael A. Wiener Cardiovascular Institute

  • Prodromos Anthopoulos, MD · The Medicines Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651780 on ClinicalTrials.gov