ECASS I
(1995)Objective
To evaluate the efficacy and safety of tPA (1.1mg/kg) given within 6 hours in acute ischemic stroke .
Study Summary
• tPA given within 6 hours, at 1.1mg/kg lead to more hemorrhages in the treatment group.
Intervention
tPA, administered within 6 hours.
Inclusion Criteria
Patients with acute ischemic stroke, within 6 hours of symptom onset.
Study Design
Arms: tPA treatment arm vs. placebo control arm.
Patients per Arm: tPA: 300, Placebo: 300
Outcome
• Primary Outcome (median mRS and Barthel Index at 90 days) showed no statistically significant difference between alteplase and placebo; • Target Population Analysis: significant difference in mRS favoring alteplase (P = .035); • Post-hoc Global Endpoint Analysis: Showed a significant increase in favorable outcome with alteplase (OR 1.5, 95% CI 1.1-2.0, p=0.008); • Post-hoc Dichotomized mRS (0-1): Alteplase showed a statistically significant benefit (OR 1.4, 95% CI 1.0 to 2.0, p=0.044; effect size: 8%); • Post-hoc Dichotomized NIHSS (0-1): Alteplase showed a statistically significant benefit (OR 1.9, 95% CI 1.4 to 2.8, p=0.001; effect size: 14%); • Post-hoc Dichotomized Barthel Index (95-100): Alteplase did not show a statistically significant benefit (P=0.102; OR, 1.3; 95% CI, 0.9 to 1.8; effect size: 6%); • Mortality: No statistically significant difference between groups; • Intracerebral Hemorrhage: Overall incidence not significantly different, but large parenchymal hemorrhages were more frequent with alteplase.