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Low INR to Minimize Bleeding With Mechanical Valves Trial

Bleeding Post-mechanical Valve Replacement | Thromboembolism Post-mechanical Valve Replacement

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

Inclusion criteria:

* Age is 18 or older at the time of enrolment
* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago
* Written informed consent from either the patient or substitute decision maker

Exclusion criteria:

* Has a second implanted mechanical valve (any position)
* Lower boundary of planned INR range is less than 2.0
* Pregnant or expecting to become pregnant during the study follow-up

Study Location

London Health Sciences Centre Research Inc.
London Health Sciences Centre Research Inc.
London, Ontario
Canada

Contact Study Team

Primary Contact

Linrui Guo, MD

Hamilton General Hospital
Hamilton General Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Emilie Belley-Cote, MD

[email protected]
905-527-4322
The Ottawa Hospital Research Institute
The Ottawa Hospital Research Institute
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Joseph Shaw, MD

Jewish General Hospital
Jewish General Hospital
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Mark Blostein, MD

Study Sponsored By
Population Health Research Institute
Participants Required
More Information
Study ID: NCT03636295