European and Australian Cooperative Stroke Study II "ECASS-II"

Completed

Phase 3 Results

Trial Description

To assess the safety and efficacy of intravenous thrombolysis with alteplase within 6 hours of stroke onset.

Interventions

Trial Design

Randomized, double-blind, controlled trial of 800 patients at 108 centers in Europe, Australia and New Zealand.

Patient Involvement

409 patients received IV rt-PA (0.9 mg/kg) and 391 received placebo.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Scale at day 90.
Secondary NIHSS total score, change to day 30, and combination of Barthel and Rankin scores at day 90.

Sponsors

Boehringer-Ingelheim