Aspirin Or Warfarin To Prevent Stroke

NCT00004728 | Terminated Phase 3

• 1 other identifier: R01NS036643
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether aspirin or warfarin is more effective in preventing stroke in patients with intracranial stenosis.

Conditions

Stroke; Cerebral Infarction; Atherosclerosis; Constriction, Pathologic

Keywords

stroke; cerebral infarction; warfarin; coumadin; aspirin; ASA; acetysalicylic acid; atherosclerosis; stenosis; intracranial; artery; arteries; transient ischemic attack; TIA; minorities

Interventions

Warfarin DRUG

Aspirin DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TIA or non-severe stroke within 90 days prior to randomization (including day 90)
• 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

You may not qualify if:

• Extracranial carotid stenosis (\> 50 percent) ipsilateral to stenosis of the intracranial carotid artery or MCA (ie.tandem stenoses, either of which could have caused patient's symptoms)
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Atherosclerosis; Constriction, Pathologic; Ischemic Attack, Transient

Interventions

Warfarin; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marc Chimowitz

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 25, 2000
• First Posted: February 28, 2000
• Study Completion: July 1, 2003
• Last Updated: June 6, 2006

Record last verified: 2006-06

Locations

US (1)