drugset / Trial / NCT00132509
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 0.8 mg/kg | Intravenous |
| Subject | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |