Low INR to Minimize Bleeding With Mechanical Valves Trial

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University; Population Health Research Institute
• Collaborator: Hamilton Health Sciences Corporation
• Treatments: Warfarin

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