To evaluate the safety and efficacy of rt-PA in patients with acute ischemic stroke.
- Tissue plasminogen activator (Activase®)Drug
Other Names: Alteplase; tPA Intervention Desc: Thrombolytic
Randomized, prospective, multi-center, double-blind, placebo-controlled trial of 620 patients at 75 centers.
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.
|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.|