African American Antiplatelet Stroke Prevention Study

How to edit trial information: Log in, click on the word [edit] to the right of the section you would like to edit, type in the appropriate information, click save page at the bottom when you are done. The template is the minimum elements required by the World Health Organization. You can add additional sections. More help to add a trial here.

Complete Title of 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)

1800

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)

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.

Template:WH

Template:WS