Warfarin and Antiplatelet Vascular Evaluation

• Status: Unknown status
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the addition of warfarin (a blood-thinning medication) to an antiplatelet therapy like aspirin is better than antiplatelet therapy alone (i.e. usual treatment) for the prevention of leg surgery, heart attacks, stroke and death in people with peripheral vascular disease.

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

Details

• Lead Sponsor: Anand, Sonia, M.D.
• Collaborators: Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Ontario
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• Intermittent claudication with objective evidence of PVD (e.g. ankle-brachial index [ABI] < 0.90)

• Ischemic rest pain of the lower limbs

• Ischemic non-healing ulcers or focal gangrene

• Amputation for vascular causes

• Previous peripheral vascular revascularization (angioplasty or bypass surgery)

• Blue toe syndrome

• Other significant peripheral arterial disease (e.g. carotid stenosis)

• Vascular disease and evidence of asymptomatic peripheral arterial disease [PAD] (i.e. ABI < 0.90)

Exclusion Criteria:

Temporary:

• Potential subjects will be temporarily excluded if they need to undergo:

• vascular diagnostic (angiography) or interventional procedures (arterial bypass graft surgery or angioplasty); or

• limb amputation for vascular insufficiency.

Permanent:

• Subjects will be excluded for the following:

• active bleeding or high risk bleeding;

• clear indication for long-term warfarin use (i.e. atrial fibrillation);

• previous allergy or intolerance to warfarin;

• stroke in the last 6 months;

• renal failure requiring dialysis;

• known significant abdominal aortic or cerebral aneurysm;

• peripheral arterial aneurysms (iliac or femoral) without evidence of lower limb ischemia;

• significant liver disease (i.e. cirrhosis);

• cancer with a life expectancy < 6 months;

• anticipated non-adherence to warfarin;

• excessive alcohol use;

• pregnancy or planning to become pregnant; or

• failure to provide informed consent.