Low INR to Minimize Bleeding With Mechanical Valves Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Thrombosis/thromboembolism — Through study completion, an expected mean of 2-3 years
  Number of patients who have at least one of the following: ischemic stroke, systemic thromboembolism, and valve thrombosis
• Major bleeding — Through study completion, an expected mean of 2-3 years
  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

Trial sites (45)

+ 5 more sites — see the full list on the official registry below.

On this site

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