Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004727
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-25
Brief Title:
Antiplatelet Therapy to Prevent Stroke in African Americans
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
African American Antiplatelet Stroke Prevention Study
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 500mgday and aspirin 650mgday 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: