We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Warfarin Versus Aspirin Recurrent Stroke Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00027066
First Posted: November 21, 2001
Last Update Posted: June 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Columbia University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027066


Locations
United States, New York
Columbia University Health Sciences
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: J. P. Mohr, M.D. Columbia University Health Sciences
  More Information

Additional Information:
Responsible Party: Jay Preston Mohr, MD, Columbia University
ClinicalTrials.gov Identifier: NCT00027066     History of Changes
Other Study ID Numbers: R01NS028371 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2001
First Posted: November 21, 2001
Last Update Posted: June 17, 2011
Last Verified: June 2011

Keywords provided by Columbia University:
stroke
aspirin
warfarin

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