European Cooperative Acute Stroke Study II

Because of the conflicting results from the two populations in ECASS I and the fact that the 1995 study by the National Institute of Neurological Disorders and Stroke (NINDS) showed efficacy of rtPA within 3 hr of stroke onset, ECASS II was undertaken (14). In ECASS II, 800 patients were enrolled and assigned to rtPA or placebo, with stratification for time from onset of stroke symptoms (0 to 3 hr or 3 to 6 hr). The primary endpoint was the mRS at 90 days, dichotomized for favorable outcome (score 0-1) and unfavorable outcome (score 2-6). Another difference in ECASS II was an rtPA dose of 0.9 mg/kg. The CT scan exclusions were stricter than in ECASS I: If more than a third of the MCA territory showed signs of brain swelling, patients were excluded. A training course was also implemented to improve the quality of CT-scanning procedures and assessment.

Measurement of the trial's primary endpoints did not show significant differences. A favorable outcome was seen in 165 (40.3%; 95% confidence interval, CI: 35.6-45.4) of the rtPA-treated group versus 143 (36.6%; 95% CI: 31.8-41.6). The absolute difference was 3.7% ( p = 0.277) in favor of rtPA. The rate of parenchymal hemorrhage was higher in the rtPA group (11.8%) than in the placebo group (3.8%). However, the 30- and 90-day mortality rates were not significantly different.

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