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Article
October 4, 1995

ECASS: Lessons for Future Thrombolytic Stroke Trials

Author Affiliations

From the Department of Neurology, the Medical Center of Central Massachusetts and the University of Massachusetts Medical School, Worcester (Dr Fisher); New England Medical Center and Tufts University School of Medicine, Boston, Mass (Dr Pessin); and the Cleveland (Ohio) Clinic Foundation (Dr Furian).

JAMA. 1995;274(13):1058-1059. doi:10.1001/jama.1995.03530130064029
Abstract

The European Cooperative Acute Stroke Study (ECASS)1 marks an important milestone along the road toward an effective therapy for acute ischemic stroke. Well-conceived and performed, ECASS is the first large, randomized, blinded study of high-dose intravenous recombinant tissue plasminogen activator (rt-PA) designed to determine if this thrombolytic therapy is efficacious and safe in acute stroke patients. More than 600 patients were recruited within 6 hours of stroke onset at 75 centers in 14 countries, demonstrating that large multinational acute stroke therapy trials are feasible and can accrue patients more rapidly than anticipated. Most importantly, current hypotheses about preventing the conversion of ischemic tissue to completed infarction suggest that early initiation of thrombolytic or neuroprotective therapy2 is essential. ECASS and the earlier monoganglioside GM1 trial3 demonstrate that early initiation is possible.

See also p 1017.

Disappointingly, the intention-to-treat analysis for clinical efficacy revealed no benefit for rt-PA intervention;

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