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Warfarin Versus Aspirin Recurrent Stroke Study

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Active Aspirin
Active Warfarin
Aspirin placebo
Warfarin placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, aspirin, warfarin

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Active Warfarin and Aspirin Placebo

Active Aspirin and Warfarin Placebo

Arm Description

One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.

One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 20, 2001
Last Updated
June 16, 2011
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00027066
Brief Title
Warfarin Versus Aspirin Recurrent Stroke Study
Official Title
A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 1993 (undefined)
Primary Completion Date
June 2000 (Actual)
Study Completion Date
November 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, aspirin, warfarin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2206 (false)

8. Arms, Groups, and Interventions

Arm Title
Active Warfarin and Aspirin Placebo
Arm Type
Active Comparator
Arm Description
One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo.
Arm Title
Active Aspirin and Warfarin Placebo
Arm Type
Active Comparator
Arm Description
One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo.
Intervention Type
Drug
Intervention Name(s)
Active Aspirin
Intervention Description
325mg tablet daily
Intervention Type
Drug
Intervention Name(s)
Active Warfarin
Intervention Description
2mg scored tablet daily
Intervention Type
Drug
Intervention Name(s)
Aspirin placebo
Intervention Description
325mg aspirin placebo pill
Intervention Type
Drug
Intervention Name(s)
Warfarin placebo
Intervention Description
2mg scored placebo tablet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. P. Mohr, M.D.
Organizational Affiliation
Columbia University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Health Sciences
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Warfarin Versus Aspirin Recurrent Stroke Study

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