Antiplatelet Therapy to Prevent Stroke in African Americans

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00004727
First received: February 25, 2000
Last updated: June 23, 2005
Last verified: June 2003
  Purpose

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.


Condition Intervention Phase
Stroke
Cerebral Infarction
Drug: aspirin
Drug: ticlopidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: African American Antiplatelet Stroke Prevention Study

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

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.

  Eligibility

Ages Eligible for Study:   29 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004727

Locations
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3227
Sponsors and Collaborators
Investigators
Principal Investigator: Philip B. Gorelick, M.D., M.P.H Rush University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004727     History of Changes
Other Study ID Numbers: R01NS33430
Study First Received: February 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
African American
antiplatelet
aspirin
ASA
acetylsalicylic acid
ticlopidine
prevention
stroke
cerebral infarction
Chicago
non-cardioembolic ischemic stroke

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Ticlopidine
Aspirin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014