To test the efficacy and relative safety of rtPA versus placebo.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
Placebo-controlled, double-blind, randomized study of 142 patients at 42 centers.
Patients were randomized to receive IV rt-PA (0.9 mg/kg) or placebo for one hour.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Clinical improvement as measured by a decrease of >=4 points on the National Institutes of Health Stroke Scale (NIHSS) or complete resolution of symptoms from baseline to 21 hours and from baseline to 30 days. Also, the volume of cerebral infarction as measured by CT scan at 30 days.|
|Secondary||Mortality at 90 days and functional outcome as measured by the Barthel Index and modified Rankin scale at days 30 and 90.|