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

Terminated

Phase 2 Results

Trial Description

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

Conditions

Interventions

  • Alteplase Drug
    Other Names: Actilyse; Activase; 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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".

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin score at day 90.
Primary Modified Rankin score day 90 Yes

Sponsors