African American Antiplatelet Stroke Prevention Study

# Complete Title of Study
African American Antiplatelet Stroke Prevention Study

# Study Acronym (The trial's abbreviation if there is one)
AAASPS

# Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator: Philip B. Gorelick, M.D., M.P.H  Rush University Medical Center

# Overview of Trial
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.

# Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Stroke
Cerebral Infarction

# Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase IV

# Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Prevention, Randomized, Double-Blind

# Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported

# Primary Pre-Specified Endpoint
None reported

# Secondary Endpoints
None reported

# Inclusion Criteria
- 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

# Exclusion Criteria
- 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
- 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)

# Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

# Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

# Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

# Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
None reported

# Conclusions of the Investigators (Quote the investigators conclusions here)
None reported

# Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported

# Slides
None reported

# Video Commentary
None reported

# References (How to insert a reference)
None reported

# External sites for further information (How to insert links)
None reported

# Detailed information about the trial

# Ages
29 years to 85 years

# Gender (Indicate whether men, women or both were enrolled)
Both

# Accepts Healthy Volunteers (Answer yes or no)
No

# Enrollment Period (Study start and end date)
None reported

# Recruitment Status (explanation)
Completed

# Enrollment (Total number of patients enrolled)

# Study Sponsor (e.g. Investigator initiated or company name)
National Institute of Neurological Disorders and Stroke (NINDS)

# Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
National Institute of Neurological Disorders and Stroke (NINDS)
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