Warfarin Versus Aspirin Recurrent Stroke Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00027066
First received: November 20, 2001
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Stroke
Drug: Active Aspirin
Drug: Active Warfarin
Drug: Aspirin placebo
Drug: Warfarin placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Columbia University:

Estimated Enrollment: 2206
Study Start Date: June 1993
Study Completion Date: November 2001
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Warfarin and Aspirin Placebo
One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Drug: Active Warfarin
2mg scored tablet daily
Drug: Aspirin placebo
325mg aspirin placebo pill
Active Comparator: Active Aspirin and Warfarin Placebo
One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
Drug: Active Aspirin
325mg tablet daily
Drug: Warfarin placebo
2mg scored placebo tablet

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027066

Locations
United States, New York
Columbia University Health Sciences
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: J. P. Mohr, M.D. Columbia University Health Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Jay Preston Mohr, MD, Columbia University
ClinicalTrials.gov Identifier: NCT00027066     History of Changes
Other Study ID Numbers: R01NS28371, R01NS028371
Study First Received: November 20, 2001
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
stroke
aspirin
warfarin

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014