StrokePhase 3NCT00027066
Warfarin Versus Aspirin Recurrent Stroke Study
A Phase 3 study testing Active Aspirin and Active Warfarin in people with Stroke, run by Columbia University at 1 site in United States.
Trial summary
The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active Aspirin and Active Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,206 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1993to Nov 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Health Sciences
New York, New York, 10032
About this study
Official title: A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke
The goal of this study is to compare aspirin to warfarin for the prevention of recurrent stroke.
Read the 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.
- Conditions
- Stroke
- Being tested
- Active Aspirin, Active Warfarin, Aspirin placebo, Warfarin placebo
- Keywords
- stroke, aspirin, warfarin
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active AspirinDrug
325mg tablet daily
Active WarfarinDrug
2mg scored tablet daily
Aspirin placeboDrug
325mg aspirin placebo pill
Warfarin placeboDrug
2mg scored placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Active Warfarin and Aspirin Placebo | Active comparator | One 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo. Receives: Drug: Active Warfarin; Drug: Aspirin placebo |
| Active Aspirin and Warfarin Placebo | Active comparator | One 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo. Receives: Drug: Active Aspirin; Drug: Warfarin placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2001 (estimated)
- Study startJun 1993
- Primary completionJun 2000
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,206 participants
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- J. P. Mohr, M.D., Principal investigator, Columbia University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027066
- Sponsor's protocol ID
- R01NS028371
- Other IDs
- R01NS028371
- Status last verified
- Jun 2011
- First submitted
- 20 Nov 2001
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Warfarin and Aspirin for the Prevention of Recurrent Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00027066
- Acronym / sponsor ID
- R01NS028371
- Conditions
- Stroke
- Keywords
- stroke, aspirin, warfarin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,206 participants
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 1993
- Primary completion
- Jun 2000 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 21 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Warfarin and Aspirin Placebo | Active comparator | Drug: Active Warfarin, Drug: Aspirin placeboOne 2 mg scored tablet daily of Warfarin and one 325 mg tablet daily of aspirin placebo. |
| Active Aspirin and Warfarin Placebo | Active comparator | Drug: Active Aspirin, Drug: Warfarin placeboOne 325 mg tablet daily of aspirin and one 2 mg scored tablet daily of Warfarin placebo. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Aspirin325mg tablet daily | Drug | Active Aspirin and Warfarin Placebo |
| Active Warfarin2mg scored tablet daily | Drug | Active Warfarin and Aspirin Placebo |
| Aspirin placebo325mg aspirin placebo pill | Drug | Active Warfarin and Aspirin Placebo |
| Warfarin placebo2mg scored placebo tablet | Drug | Active Aspirin and Warfarin Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. P. Mohr, M.D. principal investigator
Columbia University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Aspirin and Active Warfarin in people with Stroke, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2011.