Rt-PA in the Treatment of Acute Ischemic Stroke

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

Trial Design

  • Purpose: Treatment

Patient Involvement

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.

Outcomes

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

Sponsors