StrokePhase 4NCT00004727
Antiplatelet Therapy to Prevent Stroke in African Americans
A Phase 4 study testing aspirin and ticlopidine 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 African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. Read more about this study
- Who is it for?
- Ages 29 to 85 years
- Conditions the study is for
- Stroke, Cerebral Infarction
- What is being tested?
- aspirin and ticlopidine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 29 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African Americans are eligible if they had a non-cardioembolic ischemic stroke at lease 7 days, but no more than 90 days before entering the trial.
- African American
- 29-85 years of age
- Non-cardioembolic cerebral infarct
- Onset of entry stroke at least 7 days but no more than 90 days
- CT or MRI following entry stroke and consistent with occurrence of entry stroke (i.e., shows entry infarct, shows old infarct, or shows no infarct) Measurable neurologic deficit that correlates with onset of entry stroke.
- Informed consent
- Able to follow outpatient treatment program
Who cannot join
- Volunteers with transient ischemic attack (TIA) as the potentially qualifying event, intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to the study drugs, Modified Barthel Index < 10 or childbearing potential are not eligible.
- Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism, iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid endarterectomy as preventive treatment of entry stroke.
- Mean arterial blood pressure > 130mmHg on 3 consecutive days
- Modified Barthel Index < 10
- History of dementia or neurodegenerative disease
- Severe comorbid condition such as cancer that would limit survival during 2 year follow-up period
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- Concurrent enrollment in another clinical trial
- Sensitivity or allergy to aspirin or ticlopidine
- Women of childbearing potential
- Peptic ulcer disease, active bleeding diathesis, lower gastrointestinal bleeding, platelet or other hematologic abnormality currently active or clinically active in the past year, hematuria, positive stool guaiac, prolonged PT or PTT, BUN > 40mg%, serum creatinine > 2.0mg%, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of > 1800/mm3 required for participation), or > 2 times the upper range of normal on liver function tests (SGOT, SGPT, total bilirubin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3227
About this study
Official title: African American Antiplatelet Stroke Prevention Study
The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.
Read the detailed description
Stroke is one of the important diseases that disproportionately affects African-Americans. African-American men and women are about 2 times more likely than whites to die of cerebrovascular disease or experience stroke. Scientific information about the efficacy and safety of stroke preventatives in this group is much needed, yet African-Americans and other minorities have been underrepresented in biomedical research studies. Preliminary data collected from nonwhite, predominantly African-American patients, suggest that ticlopidine is more effective than aspirin in the secondary prevention of stroke and death for these patients and that the risk of serious adverse events is lower. This is a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (650mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to compare the efficacy of ticlopidine and aspirin in the prevention of the outcome endpoints recurrent stroke, vascular death, and myocardial infarction in these African-American patients. Adverse experiences will be studied to further our understanding of the safety of these medications in this group. The study is being conducted at 50 sites experienced in the diagnosis and treatment of stroke. 1800 patients are being enrolled over 3-5 years, and each will be in the study for at least 2 years. Patients will be randomly assigned to treatment at least 7 days, but no more than 90 days after cerebral infarction. The trial promises to provide much needed information about secondary stroke prevention in African-Americans and has the support of established African-American physician, church-based, and community organizations. Enrollment of a substantial number of African-American women is anticipated. Data from these patients will significantly add to our understanding of cerebrovascular disease among black women. Furthermore, the study could also serve as an organizational framework for future studies of stroke prevention or hyperacute treatment in the African-American population.
- Conditions
- Stroke, Cerebral Infarction
- Being tested
- aspirin, ticlopidine
- Keywords
- African American, antiplatelet, aspirin, ASA, acetylsalicylic acid, ticlopidine, prevention, stroke, cerebral infarction, Chicago, non-cardioembolic ischemic stroke
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
ticlopidineDrug
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)
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 National Institute of Neurological Disorders and Stroke (NINDS)The 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Philip B. Gorelick, M.D., M.P.H, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004727
- Sponsor's protocol ID
- R01NS033430
- Status last verified
- Jun 2003
- First submitted
- 25 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African American Antiplatelet Stroke Prevention Study
- ClinicalTrials.gov ID
- NCT00004727
- Acronym / sponsor ID
- R01NS033430
- Conditions
- Stroke, Cerebral Infarction
- Keywords
- African American, antiplatelet, aspirin, ASA, acetylsalicylic acid, ticlopidine, prevention, stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- 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 African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.
Detailed description
Stroke is one of the important diseases that disproportionately affects African-Americans. African-American men and women are about 2 times more likely than whites to die of cerebrovascular disease or experience stroke. Scientific information about the efficacy and safety of stroke preventatives in this group is much needed, yet African-Americans and other minorities have been underrepresented in biomedical research studies. Preliminary data collected from nonwhite, predominantly African-American patients, suggest that ticlopidine is more effective than aspirin in the secondary prevention of stroke and death for these patients and that the risk of serious adverse events is lower. This is a multicenter, randomized, double-blind clinical trial of ticlopidine hydrochloride (500mg/day) and aspirin (650mg/day) in African-American patients with recent non-cardioembolic ischemic stroke. The primary purpose of the study is to compare the efficacy of ticlopidine and aspirin in the prevention of the outcome endpoints recurrent stroke, vascular death, and myocardial infarction in these African-American patients. Adverse experiences will be studied to further our understanding of the safety of these medications in this group. The study is being conducted at 50 sites experienced in the diagnosis and treatment of stroke. 1800 patients are being enrolled over 3-5 years, and each will be in the study for at least 2 years. Patients will be randomly assigned to treatment at least 7 days, but no more than 90 days after cerebral infarction. The trial promises to provide much needed information about secondary stroke prevention in African-Americans and has the support of established African-American physician, church-based, and community organizations. Enrollment of a substantial number of African-American women is anticipated. Data from these patients will significantly add to our understanding of cerebrovascular disease among black women. Furthermore, the study could also serve as an organizational framework for future studies of stroke prevention or hyperacute treatment in the African-American population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 29 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- African Americans are eligible if they had a non-cardioembolic ischemic stroke at lease 7 days, but no more than 90 days before entering the trial.
- African American
- 29-85 years of age
- Non-cardioembolic cerebral infarct
- Onset of entry stroke at least 7 days but no more than 90 days
Key exclusion criteria (10 listed)
- Volunteers with transient ischemic attack (TIA) as the potentially qualifying event, intracranial hemorrhage, nonatherosclerotic stroke, sensitivity or major allergy to the study drugs, Modified Barthel Index < 10 or childbearing potential are not eligible.
- Non-qualifying entry events: TIA, subarachnoid hemorrhage, cardiac embolism, iatrogenic stroke, postoperative stroke within 30 days of operation, and carotid endarterectomy as preventive treatment of entry stroke.
- Mean arterial blood pressure > 130mmHg on 3 consecutive days
- Modified Barthel Index < 10
- History of dementia or neurodegenerative disease
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 |
|---|---|---|
| aspirin | Drug | – |
| ticlopidine | Drug | – |
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 24 Jun 2005.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Philip B. Gorelick, M.D., M.P.H principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin and ticlopidine 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 8 inclusion and 10 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 24 Jun 2005. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Jun 2005.