As of April 5, 2011, the NINDS stopped enrollment of this funded study of patients presenting with transient ischemic attack (TIA) or non-disabling stroke, associated with intracranial arterial stenosis (70 to 99%), who were enrolled within 30 days of presentation.
Starting in November of 2008, subjects were randomized either to aggressive medical management alone or to aggressive medical management plus angioplasty with stenting. All patients received aspirin 325 mg/day for the entire follow-up and clopidogrel 75 mg/day for 90 days after enrollment. Medical management consisted of optimal blood pressure and LDL-cholesterol control along with a lifestyle modification program.
After enrollment of 451 patients of the planned 764 patients, which represented 59% of projected recruitment, the Data Safety Monitoring Board recommended termination of the study after it was determined that 14% of patients treated with angioplasty with stenting experienced a stroke or died within 30 days of enrollment, compared to 5.8% of patients who were treated with medical therapy alone.