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Warfarin Versus Aspirin Recurrent Stroke Study

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.
 
ClinicalTrials.gov Identifier: NCT00027066
Recruitment Status : Completed
First Posted : November 21, 2001
Last Update Posted : June 17, 2011
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Columbia University

Tracking Information
First Submitted Date  ICMJE November 20, 2001
First Posted Date  ICMJE November 21, 2001
Last Update Posted Date June 17, 2011
Study Start Date  ICMJE June 1993
Actual Primary Completion Date June 2000   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Warfarin Versus Aspirin Recurrent Stroke Study
Official Title  ICMJE A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: Active Aspirin
    325mg tablet daily
  • Drug: Active Warfarin
    2mg scored tablet daily
  • Drug: Aspirin placebo
    325mg aspirin placebo pill
  • Drug: Warfarin placebo
    2mg scored placebo tablet
Study Arms  ICMJE
  • Active Comparator: Active Warfarin and Aspirin Placebo
    One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
    Interventions:
    • Drug: Active Warfarin
    • Drug: Aspirin placebo
  • Active Comparator: Active Aspirin and Warfarin Placebo
    One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
    Interventions:
    • Drug: Active Aspirin
    • Drug: Warfarin placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
2206
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2001
Actual Primary Completion Date June 2000   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00027066
Other Study ID Numbers  ICMJE R01NS028371( U.S. NIH Grant/Contract )
R01NS028371 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay Preston Mohr, MD, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: J. P. Mohr, M.D. Columbia University Health Sciences
PRS Account Columbia University
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP