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.
Trial Stopped: End of promotion by the sponsor
- Alteplase Drug
Other Names: rt-PA Intervention Desc: IV
- DFIL Drug
Intervention Desc: Alteplase : 0.8mg/kg over 90 minutes ARM 1: Kind: Experimental Label: DFIL
- NINDS Drug
Intervention Desc: Alteplase : 0.9mg/kg over 60 minutes ARM 1: Kind: Experimental Label: NINDS
- Allocation: Randomized
- Masking: Single Blind (Subject)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patient to receive alteplase 0.9mg/kg over 60 minutes in arm with a "classical dose" and alteplase 0.8mg/kg over 90 minutes in arm with a "low dose-longer infusion".
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin score at day 90.|
|Primary||Modified Rankin score||day 90||Yes|