Low INR to Minimize Bleeding With Mechanical Valves Trial

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

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

2,625 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Population Health Research Institute

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator