Health Trials

Low INR to Minimize Bleeding With Mechanical Valves Trial

ConditionsBleeding Post-mechanical Valve ReplacementThromboembolism Post-mechanical Valve Replacement
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Warfarin

    Drug

    Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.

Treatment groups

2,625 Participants
are divided into 2 treatment groups
Group A: Reduced INR TargetExperimental treatment 1 intervention
Group B: Standard INR TargetActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Thrombosis/thromboembolism

Number of patients who have at least one of the following: ischemic stroke, systemic thromboembolism, and valve thrombosis

Time frame
Through study completion, an expected mean of 2-3 years
2

Major bleeding

Number of patients that have bleeding that results in the following: 1. Death and/or, 2. Symptomatic bleeding in critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, in a non-operated joint, or intramuscular with compartment syndrome) and/or, 3. Bleeding that causes drop of hemoglobin level by 20 g/L or more, or that requires the transfusion of 2 or more units of packed red blood cells or whole blood

Time frame
Through study completion, an expected mean of 2-3 years

Secondary outcomes

1

All cause mortality

Selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline.

Time frame
Through study completion, an expected mean of 2-3 years
2

All clinically important bleeding

Number of patients that experience all clinically important bleeding (major and minor)

Time frame
Through study completion, an expected mean of 2-3 years
3

Minor bleeding

Number of patients that experience a bleed that does not meet major bleeding criteria

Time frame
Through study completion, an expected mean of 2-3 years
4

All stroke

Number of patients that experience a strokes, including ischemic stroke, ischemic with secondary transformation, stroke of uncertain classification and hemorrhagic stroke

Time frame
Through study completion, an expected mean of 2-3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator

Source ClinicalTrials.gov
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