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Warfarin Versus Aspirin Recurrent Stroke Study

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00027066
Enrollment
2206
Registered
2001-11-21
Start date
1993-06-30
Completion date
2001-11-30
Last updated
2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, aspirin, warfarin

Brief summary

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

Detailed description

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.

Interventions

DRUGActive Aspirin

325mg tablet daily

DRUGActive Warfarin

2mg scored tablet daily

325mg aspirin placebo pill

2mg scored placebo tablet

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026