- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00125671
Warfarin and Antiplatelet Vascular Evaluation
A Phase III Randomized Trial of Warfarin Plus Antiplatelet Therapy Versus Antiplatelet Therapy Alone in Patients With Peripheral Vascular Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Population Health Research Institute, McMaster University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
---|
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)
|
Mesures de résultats secondaires
Mesure des résultats |
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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
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All cause death, MI, TIA, stroke, amputation, or revascularization of the coronary or peripheral arteries
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sonia Anand, MD PhD FRCPc, Population Health Research Institute, McMaster University
Publications et liens utiles
Publications générales
- WAVE Investigators. The effects of oral anticoagulants in patients with peripheral arterial disease: rationale, design, and baseline characteristics of the Warfarin and Antiplatelet Vascular Evaluation (WAVE) trial, including a meta-analysis of trials. Am Heart J. 2006 Jan;151(1):1-9. doi: 10.1016/j.ahj.2005.03.021.
- Warfarin Antiplatelet Vascular Evaluation Trial Investigators, Anand S, Yusuf S, Xie C, Pogue J, Eikelboom J, Budaj A, Sussex B, Liu L, Guzman R, Cina C, Crowell R, Keltai M, Gosselin G. Oral anticoagulant and antiplatelet therapy and peripheral arterial disease. N Engl J Med. 2007 Jul 19;357(3):217-27. doi: 10.1056/NEJMoa065959.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MCT-37413
- T4913
Informations sur les médicaments et les dispositifs, documents d'étude
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