StrokePhase 3NCT00004728
Aspirin Or Warfarin To Prevent Stroke
A Phase 3 study testing Warfarin and Aspirin in people with Stroke and Cerebral Infarction, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Cerebral Infarction, Atherosclerosis
- What is being tested?
- Warfarin and Aspirin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jul 2003
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TIA or non-severe stroke within 90 days prior to randomization (including day 90)
- Modified Rankin score of < 3
- High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90)
- TIA or stroke is attributed to high grade intracranial stenosis
- Age > 40 years
- Patient is able to follow an outpatient protocol(requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone
- Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent
Who cannot join
- Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms)
- Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA
- Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast
- A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (SGOT > 3x normal*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine > 3.0*
- Indication for intravenous heparin beyond randomization
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- A severe neurological deficit that renders the patient incapable of living independently
- Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
- Co-morbid conditions that may limit survival to less than five years
- Pregnancy or female in age range of childbearing potential who is not using contraception
- Enrollment in another study that would conflict with the current study
- Excluded because difficult to measure percent stenosis of these small arteries, lesions are uncommon, and prognosis of patients - With these lesions is unknown * on most recent test done within 90 days prior to randomization, including day 90
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study
The purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis.
Read the detailed description
Prevention of stroke in patients with narrowing of one of the arteries in the brain typically consists of using medications to prevent blood clots from forming. Currently, the best medication to use in this situation is unknown. The purpose of this study is to compare the effectiveness of two different medications, warfarin or aspirin, for the prevention of stroke due to narrowing of one of the large arteries in the brain. Patients must have experienced a recent transient ischemic attack (TIA) or mild stroke. Stroke of this type is thought to occur more often in minorities.
- Conditions
- Stroke, Cerebral Infarction, Atherosclerosis, Constriction, Pathologic
- Keywords
- stroke, cerebral infarction, warfarin, coumadin, aspirin, ASA, acetysalicylic acid, atherosclerosis, stenosis, intracranial, artery, arteries, transient ischemic attack, TIA, minorities
- Medical subject headings
- Stroke, Cerebral Infarction, Atherosclerosis, Constriction, Pathologic, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2000 (estimated)
- Study completionJul 2003
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.
- 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Marc Chimowitz, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004728
- Sponsor's protocol ID
- R01NS036643
- Status last verified
- Jun 2006
- First submitted
- 25 Feb 2000
- Last updated
- 6 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Study
- ClinicalTrials.gov ID
- NCT00004728
- Acronym / sponsor ID
- R01NS036643
- Conditions
- Stroke, Cerebral Infarction, Atherosclerosis, Constriction, Pathologic
- Keywords
- stroke, cerebral infarction, warfarin, coumadin, aspirin, ASA, acetysalicylic acid, atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study completion
- Jul 2003
- First posted
- 28 Feb 2000 (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 purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis.
Detailed description
Prevention of stroke in patients with narrowing of one of the arteries in the brain typically consists of using medications to prevent blood clots from forming. Currently, the best medication to use in this situation is unknown. The purpose of this study is to compare the effectiveness of two different medications, warfarin or aspirin, for the prevention of stroke due to narrowing of one of the large arteries in the brain. Patients must have experienced a recent transient ischemic attack (TIA) or mild stroke. Stroke of this type is thought to occur more often in minorities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- TIA or non-severe stroke within 90 days prior to randomization (including day 90)
- Modified Rankin score of < 3
- High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90)
- TIA or stroke is attributed to high grade intracranial stenosis
- Age > 40 years
Key exclusion criteria (12 listed)
- Extracranial carotid stenosis (> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms)
- Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA
- Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast
- A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets < 100,000*, hematocrit < 30*, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (SGOT > 3x normal*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine > 3.0*
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 |
|---|---|---|
| Warfarin | Drug | – |
| Aspirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2006.
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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.
Marc Chimowitz principal investigator
Emory University
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 Warfarin and Aspirin in people with Stroke and Cerebral Infarction, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Jun 2006. 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 was stopped early. Results are not available in the source record.
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 6 Jun 2006.