Warfarin and Antiplatelet Vascular Evaluation
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|ClinicalTrials.gov Identifier: NCT00125671|
Recruitment Status : Unknown
Verified September 2009 by Warfarin and Antiplatelet Vascular Evaluation.
Recruitment status was: Active, not recruiting
First Posted : August 1, 2005
Last Update Posted : September 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases Cardiovascular Diseases||Drug: Warfarin||Phase 3|
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, symptomatic PVD is an ominous sign that widespread atherosclerosis is present and patients with this condition suffer a threefold increase in myocardial infarction (MI), stroke, and CV death. These CV events are a consequence of rupture of an atherosclerotic plaque, which leads to platelet activation and thrombin generation, thrombus formation and occlusion of a critical blood vessel. Antiplatelet therapy has been clearly demonstrated to reduce major CV events. It is also reasonable to expect that this process may be further attenuated by the addition of an anti-thrombin agent (such as warfarin) in combination with antiplatelet agents.
WAVE is a large, international, multicentre, randomized clinical trial in high-risk PVD patients to evaluate the additional benefit of moderate intensity warfarin (target INR of 2.4-3.0) to antiplatelet therapy compared to antiplatelet therapy alone in reducing serious cardiovascular events.
There are currently 80 active centres following participants in Canada, Poland, Australia, Hungary, China, Ukraine, and the Netherlands. Following randomization to one of the two treatment groups, participants will require clinic or phone follow-up visits every 3 months for 2.5 or 3.5 years. For participants on warfarin, INRs will be measured monthly or more frequently if required. For participants who stop warfarin therapy prematurely, every attempt will be made to have them restart it
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Trial of Warfarin Plus Antiplatelet Therapy Versus Antiplatelet Therapy Alone in Patients With Peripheral Vascular Disease|
|Study Start Date :||January 2000|
|Study Completion Date :||April 2006|
- The composite of cardiovascular (CV) death, first occurrence of myocardial infarction (MI), or stroke
- The composite of CV death, first occurrence of MI, stroke, or severe ischemia requiring urgent intervention of the coronary (PTCA, CABG) or peripheral artery circulation (thrombolytic therapy, angioplasty, bypass surgery, limb amputation)
- CV death, MI, stroke, amputation, revascularization of the coronary or peripheral arteries, or admission to hospital for unstable angina with electrocardiogram (ECG) changes
- CV death, MI, stroke, transient ischemic attack (TIA), amputation or revascularization of the coronary, carotid, or leg arteries
- All cause death, MI, TIA, stroke, amputation, or revascularization of the coronary or peripheral arteries
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125671
|Population Health Research Institute, McMaster University|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Sonia Anand, MD PhD FRCPc||Population Health Research Institute, McMaster University|