To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an improved clinical outcome without increase of fatality rate.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
- Rt-PA 0.9 mg/kg verum or placebo Intravenous Drug
- Purpose: Treatment
Patients will be randomized 1:1 to receive intravenous rt-PA (alteplase 0.9mg/kg bodyweight, maximally 90mg; 10% bolus plus one hour infusion) or placebo started between 3 and 4 hours from the onset of stroke.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Primary efficacy endpoint is Modified Rankin Scale 0-1 at 90 days. Safety Endpoints: Survival at day 90, stroke related neurological deaths, symptomatic cerebral hemorrhage, cerebral herniation and symptomatic brain edema, vital signs, adverse events, laboratory parameters.|
|Secondary||Secondary efficacy endpoint is Global Outcome (Modified Rankin Scale 0-1, Barthel Index 95-100, NIHSS 0-1, Glasgow Outcome Score 0-1) at 90 days. Further efficacy parameters are ordinary disability and functional scales, infarct size on CT at various time points after stroke onset, Modified Rankin Scale at 90 days stratified by admission NIHSS and length of in-hospital stay.|
|Primary||modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90||at day 90||No|
|Secondary||Global outcome of four neurologic and disability scores combined||at day 90||No|