European Cooperative Acute Stroke Study "ECASS-I"

Completed

Phase 3 Results

Trial Description

To evaluate the safety and efficacy of rt-PA in patients with acute ischemic stroke.

Interventions

Trial Design

Randomized, prospective, multi-center, double-blind, placebo-controlled trial of 620 patients at 75 centers.

Patient Involvement

Patients were randomized to receive rt-PA (1.1 mg/kg of body weight) or placebo. A bolus of 10% of the total dose was given for 1-2 minutes followed by a 60-minute IV infusion of the remaining dose.

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index (BI) and modified Rankin Scale (RS) at 90 days.
Secondary Combined BI and RS, Scandinavian Stroke Scale (SSS) at 90 days, and 30-day mortality, early neurologic recovery (SSS) and duration of in-hospital stay.