ECASS-I
European Cooperative Acute Stroke Study
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Status:
Trial complete. Results published in October of 1995.
Purpose:
To evaluate the safety and efficacy of rt-PA in patients with acute ischemic stroke.
Design:
Randomized, prospective, multi-center, double-blind, placebo-controlled trial of 620 patients at 75 centers.
Inclusion Criteria
Acute ischemic stroke (within 6 hours of onset) and moderate to severe neurologic deficit and without major early infarct signs on initial computed tomography (CT). Ages 18-80 years.
Exclusion Criteria
Severe hemispheric stroke syndrome, initial SSS >50-58 total points, patients already improving, preexisting disabling neurologic disease or preexisting concomitant medical conditions, spontaneous intracranial or intracerebral hemorrhage or major early infarct signs on CT scan.
Patient Involvement:
Patients were randomized to receive rt-PA (1.1 mg/kg of body weight) or placebo. A bolus of 10% of the total dose was given for 1-2 minutes followed by a 60-minute IV infusion of the remaining dose.
Primary Outcome:
Barthel Index (BI) and modified Rankin Scale (RS) at 90 days.
Secondary Outcome:
Combined BI and RS, Scandinavian Stroke Scale (SSS) at 90 days, and 30-day mortality, early neurologic recovery (SSS) and duration of in-hospital stay.
Results:
There was no difference in primary endpoints in the intention to treat analysis but the explanatory analysis of the target population showed a significant difference (p=0.035) in the RS in favor of rt-PA treated patients.
Source of Information:
JAMA 1995 Oct 4;274(13):1017-25.
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Web Links and Publications:
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This information last updated on: 9/21/2000
Reviewed on: 07/30/2008.
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