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Research

Photo for WAVE

WAVE

Official Title

The Warfarin Antiplatelet Vascular Evaluation (WAVE) Trial

Status

Completed

Overview

The WAVE trial was a phase III international, multi-centres RCT of warfarin plus antiplatelet therapy versus antiplatelet therapy alone in patients with peripheral arterial disease (one of the largest trials to-date conducted in patients with peripheral arterial disease)

Study Design

Randomized, open label, parallel group design.

Primary Endpoint

The co-primary endpoints were: A. Composite of CV death, MI, or stroke, B. A. or severe ischemia requiring reperfusion/reconstruction of the coronary or peripheral arterial circulation. Secondary endpoints: a) CV death, MI, stroke, amputation, revascularization of the coronary or peripheral arterial circulation, b) CV death, MI, stroke, amputation, revascularization and severe coronary ischemia with ECG changes; c) death, MI, TIA, stroke, amputation, coronary or peripheral revascularization and severe coronary ischemia with ECG changes. All primary and secondary endpoints were adjudicated.

Number of Patients

2161

Number of Sites

80

Number of Countries

7

Study Period

2000–2006

Principal Investigator

Sonia Anand

Program Manager

Sumathy Rangarajan

Key Publications

  • 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;151:1-9.
  • 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;357:217-27.