Warfarin-Aspirin Symptomatic Intracranial Disease Study "WASID"

Completed

Phase 3 Results

Eligibility Criteria

Inclusion Criteria

Patients who present within 90 days of a transient ischemic attack (TIA) or non-severe stroke attributed to angiographically-proven high-grade (50 - 99%) stenosis of a major intracranial artery (internal carotid artery, middle cerebral artery stem, vertebral artery, or basilar artery), and who have a modified Rankin Scale (MRS) score > 3, are eligible for this study.

Exclusion Criteria

Females of childbearing potential and persons with > 50% stenosis of the ipsilateral external carotid, isolated stenosis of the anterior cerebral artery, posterior cerebral artery, middle cerebral artery (MCA) division, or a distal branch of the MCA, who have intracranial or extracranial arterial dissection, Moya Moya disease, vasculitis, radiation-induced vasculopathy, or fibromuscular dysplasia, who have 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, or left atrial spontaneous echo contrast, who have any of the following contraindications to the use of either warfarin or aspirin: active peptic ulcer disease, active bleeding diathesis, platelets < 100,000/mm3, hematocrit < 30, a 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, or plasma creatinine > 3.0, who require intravenous heparin after randomization, who have a severe neurological deficit, dementia, or psychiatric problem that precludes living independently and reliably following an outpatient program, who have a co-morbid conditions that may limit survival to less than 5 years, or who are enrolled in another study, will be excluded from this trial.