Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
INTERVENTIONAL
2003-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Warfarin
Aspirin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Modified Rankin score of \< 3
* High grade stenosis (50 to 99 percent) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery,and basilar artery) documented by conventional angiography within 90 days prior to randomization (including day 90)
* TIA or stroke is attributed to high grade intracranial stenosis
* Age \> 40 years
* Patient is able to follow an outpatient protocol(requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone
* Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent
Exclusion Criteria
* Isolated stenosis of the anterior cerebral artery, posterior cerebral artery, MCA division, or a distal branch of the MCA
* Intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy, fibromuscular dysplasia
* Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast
* A contraindication to the use of either warfarin or aspirin e.g. active peptic ulcer disease, active bleeding diathesis, platelets \< 100,000\*, hematocrit \< 30\*, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (SGOT \> 3x normal\*, cirrhosis), allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure \> 180 mm Hg or diastolic pressure \> 115mm Hg), positive stool guaiac that is not attributable to hemorrhoids, creatinine \> 3.0\*
* Indication for intravenous heparin beyond randomization
* A severe neurological deficit that renders the patient incapable of living independently
* Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
* Co-morbid conditions that may limit survival to less than five years
* Pregnancy or female in age range of childbearing potential who is not using contraception
* Enrollment in another study that would conflict with the current study
* Excluded because difficult to measure percent stenosis of these small arteries, lesions are uncommon, and prognosis of patients - With these lesions is unknown \* on most recent test done within 90 days prior to randomization, including day 90
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Chimowitz
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.