European Cooperative Acute Stroke Study: Trial Protocol
The European Cooperative Acute Stroke Study (ECASS) is a double-blind, randomized placebo controlled trial of rt-PA (alteplase) in acute ischemic hemispheric stroke in which thrombolysis is initiated 1–6 h following the onset of symptoms. ECASS is an all-European multicenter study, with 14 participating nations. The aim is to assess the efficacy and safety of rt-PA in patients with acute ischemic stroke, by administering a dose of 1.1 mg/kg as follows: 10% of the dosage in bolus intravenously and the remaining 90% in an infusion over a period of 60 min. The total dose must not exceed 100 mg. The activities of daily living, evaluated by means of the Barthel Index  and Rankin Scale , are the measures of efficacy and represent the primary endpoints. Secondary endpoints are overall mortality and two neurological scales (Scandinavian Stroke Scale  and NIH Stroke Scale ). The main hypothesis regarding efficacy is the following: there is a difference between the alteplase and placebo groups in activities of daily living defined as a difference of 15 points in the Barthel Index 90 days after treatment. The safety is evaluated on the basis of cerebral hemorrhagic events, global rate of adverse effects, and systematic screening of differences between treated patients and controls in terms of laboratory values.
KeywordsAcute Ischemic Stroke Barthel Index Neurological Exam Randomized Placebo Control Trial Middle Cerebral Artery Territory
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