About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Warfarin
Treatment groups
Sponsors and collaborators
Population Health Research Institute
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator