Low INR to Minimize Bleeding With Mechanical Valves Trial
Population Health Research Institute
2,625 participants
Sep 5, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- 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
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Interventions
Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
Locations(35)
View Full Details on ClinicalTrials.gov
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NCT03636295