Skip to main content
OpenTrials
Completed

NCT Number: NCT00027066

Warfarin Versus Aspirin Recurrent Stroke Study

The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Columbia University Health Sciences

New York, 10032, United States

About this study

This study compared aspirin to warfarin to determine optimal therapy for the prevention of recurrent stroke. Both drugs slow clotting of the blood. Blood clots are involved in the final stages of the most common type of stroke due to blockage of the vessels that supply oxygen-rich blood to the brain. Aspirin affects the blood platelets, while warfarin inhibits circulating clotting proteins in the blood. Numerous previous studies have proven that use of aspirin reduces recurrent stroke by about 25 percent. Part of the controversy about aspirin versus warfarin for stroke prevention has been the thinking among clinicians that warfarin may be a better blood thinner than aspirin to prevent almost all forms of stroke, but that it has greater side effects, increased risk of hemorrhage, and higher costs due to the need for blood tests to monitor the treatment effect for patients.

To make the aspirin and warfarin arms of the study as unbiased as possible, the investigators matched both groups of patients for primary stroke severity, age, gender, education, and race/ethnicity. The two groups were also matched for stroke risk factors, including hypertension, diabetes, cardiac disease, smoking, alcohol consumption, and physical activity. The investigators used an aspirin dose of 325 mg/day and a warfarin dose specifically tailored to each individual patient.

This study found that aspirin works as well as warfarin in helping to prevent recurrent strokes in most patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Acceptable candidates for warfarin therapy
  • Had an ischemic stroke within the previous 30 days
  • Had scores of 3 or more on the Glasgow Outcome Scale

Exclusion:

  • Base-line INR above the normal range (more than 1.4)
  • History of stroke due to a procedure or that was attributed to high-grade carotid stenosis for which surgery was planned
  • History of stroke associated with an inferred cardioembolic source

Treatment and study plan

Active Aspirin

Drug

325mg tablet daily

Active Warfarin

Drug

2mg scored tablet daily

Aspirin Placebo

Drug

325mg aspirin placebo pill

Warfarin placebo

Drug

2mg scored placebo tablet

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke

Important dates

Study start
1993
Primary completion
2000
Study completion
2001
First posted
Nov 21, 2001
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.