drugset / Trial / NCT00132509

FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke

NCT00132509

Phase 2 Terminated 500 enrolled Hospices Civils de Lyon
RandomizedParallel-groupSingle-blindTreatment

Summary

Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours. Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion". This is a study of the outcome at 90 days.

Timeline

Start
2001-09
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Alteplase Protein / enzyme biologic 0.8 mg/kg Intravenous
Subject Alteplase Protein / enzyme biologic 0.9 mg/kg Intravenous

Indications