To assess the efficacy and safety of 0.9 mg/kg intravenous rtPA (Alteplase) vs placebo in acute ischemic stroke patients treated within 3 to 5 hours of stroke onset.
- Tissue plasminogen activator (Activase®)Drug
Other Names: Alteplase; tPA Intervention Desc: Thrombolytic
Placebo-controlled, double-blind, randomized study of 613 patients at 140 centers.
272 patients received Alteplase and 275 received placebo.
|Type||Measure||Time Frame||Safety Issue|
|Primary||NIH Stroke Scale (NIHSS) score <= 1.|
|Secondary||Barthel Index, modified Rankin scale, and Glasgow Outcome Scale at 30 days and 90. Serious adverse events were also assessed.|