NCT00125671

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 treatment) for the prevention of leg surgery, heart attacks, stroke and death in people with peripheral vascular disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 29, 2009

Status Verified

September 1, 2009

First QC Date

July 29, 2005

Last Update Submit

September 27, 2009

Conditions

Peripheral Vascular DiseasesCardiovascular Diseases

Keywords

Warfarin and Antiplatelet Vascular EvaluationPeripheral vascular diseaseAtherosclerosiscardiovascular eventsIschemiaoral anticoagulantslow ankle-brachial indexmoderate intensity warfarinInternational normalized ratio [INR]

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Interventions

WarfarinDRUG

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Health Research Institute, McMaster University

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 16368284BACKGROUND

  • 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.

    PMID: 17634457DERIVED

MeSH Terms

Conditions

Peripheral Vascular DiseasesCardiovascular DiseasesAtherosclerosisIschemia

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Vascular DiseasesArteriosclerosisArterial Occlusive DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sonia Anand, MD PhD FRCPc

    Population Health Research Institute, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

January 1, 2000

Study Completion

April 1, 2006

Last Updated

September 29, 2009

Record last verified: 2009-09

Locations

CA(1)