Status:
UNKNOWN
Warfarin and Antiplatelet Vascular Evaluation
Lead Sponsor:
Anand, Sonia, M.D.
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Conditions:
Peripheral Vascular Diseases
Cardiovascular Diseases
Eligibility:
All Genders
35-85 years
Phase:
PHASE3
Brief 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 tr...
Detailed Description
Atherosclerosis is the underlying cause of peripheral vascular disease (PVD) of the lower extremities, and leads to intermittent claudication, leg ulceration and gangrene. More importantly, symptomati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT00125671
Start Date
January 1 2000
End Date
April 1 2006
Last Update
September 29 2009
Active Locations (1)
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1
Population Health Research Institute, McMaster University
Hamilton, Ontario, Canada, L8L 2X2