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Low INR to Minimize Bleeding With Mechanical Valves Trial

NCT03636295 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2625

Last updated 2026-01-06

No results posted yet for this study

Summary

This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.

Conditions

  • Bleeding Post-mechanical Valve Replacement
  • Thromboembolism Post-mechanical Valve Replacement

Interventions

DRUG

Warfarin

Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Emilie Belley-Côté, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Belgium
  • Botswana
  • Brazil
  • Cameroon
  • Canada
  • China
  • Denmark
  • Germany
  • Italy
  • Nepal
  • Netherlands
  • Pakistan
  • Russia
  • Saudi Arabia
  • South Korea
  • Spain
  • 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 NCT03636295 on ClinicalTrials.gov