Warfarin and Antiplatelet Vascular Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Warfarin and Antiplatelet Vascular Evaluation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Information provided by:
Warfarin and Antiplatelet Vascular Evaluation
ClinicalTrials.gov Identifier:
NCT00125671
First received: July 29, 2005
Last updated: September 27, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Cardiovascular Diseases
Drug: Warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Randomized Trial of Warfarin Plus Antiplatelet Therapy Versus Antiplatelet Therapy Alone in Patients With Peripheral Vascular Disease

Resource links provided by NLM:


Further study details as provided by Warfarin and Antiplatelet Vascular Evaluation:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 2400
Study Start Date: January 2000
Estimated Study Completion Date: April 2006
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, 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

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125671

Locations
Canada, Ontario
Population Health Research Institute, McMaster University
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Anand, Sonia, M.D.
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Sonia Anand, MD PhD FRCPc Population Health Research Institute, McMaster University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00125671     History of Changes
Other Study ID Numbers: MCT-37413, T4913
Study First Received: July 29, 2005
Last Updated: September 27, 2009
Health Authority: Canada: Health Canada

Keywords provided by Warfarin and Antiplatelet Vascular Evaluation:
Warfarin and Antiplatelet Vascular Evaluation
Peripheral vascular disease
Atherosclerosis
cardiovascular events
Ischemia
oral anticoagulants
low ankle-brachial index
moderate intensity warfarin
International normalized ratio [INR]

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Cardiovascular Diseases
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014