African American Antiplatelet Stroke Prevention Study
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Complete Title of Study
Complete Title of Study
African American Antiplatelet Stroke Prevention Study
Study Acronym (The trial’s abbreviation if there is one)
Study Acronym (The trial’s abbreviation if there is one)
AAASPS
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator: Philip B. Gorelick, M.D., M.P.H Rush University Medical Center
Overview of Trial
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.)
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
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase IV
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Phase I Trials
These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.
Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.
Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.
Phase IV Trials
After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Prevention, Randomized, Double-Blind
Study Arms and How They Were Treated (Intervention) (Explanation here)
Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
In a clinical study, participants are often divided into groups.
In interventional studies, participants are prospectively assigned to arms and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.
In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.
Source
Primary Pre-Specified Endpoint
Primary Pre-Specified Endpoint
None reported
Secondary Endpoints
Secondary Endpoints
None reported
Inclusion Criteria
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
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)
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)
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)
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)
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)
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Slides
Slides
None reported
Video Commentary
Video Commentary
None reported
External sites for further information (How to insert links)
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Detailed information about the trial
Ages
Ages
29 years to 85 years
Gender (Indicate whether men, women or both were enrolled)
Gender (Indicate whether men, women or both were enrolled)
Both
Accepts Healthy Volunteers (Answer yes or no)
Accepts Healthy Volunteers (Answer yes or no)
No
Enrollment Period (Study start and end date)
Enrollment Period (Study start and end date)
None reported
Recruitment Status (explanation)
Recruitment Status (explanation)
Completed
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: participants are not yet being recruited or enrolled
- Recruiting: participants are currently being recruited and enrolled
- Enrolling by invitation: participants are being (or will be) selected from a predetermined population
- Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
- Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
- Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
- Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrollment (Total number of patients enrolled)
Enrollment (Total number of patients enrolled)
1800
Study Sponsor (e.g. Investigator initiated or company name)
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)
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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