Neuroprotection Impact of Cyclosporin A in Cerebral Infarction "CsAStroke"

Completed

Phase 2 Results N/A

Trial Description

The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.
Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.

Conditions

Interventions

  • Ciclosprin A Drug
    Intervention Desc: The dose in this study was 2 mg / kg, administered within 15 min after beginning of thrombolysis. The treatment of the study consists of a single bolus injection. This dose was chosen according to the results of tolerance in myocardial infarction and unknown pharmacodynamic and safety data
    ARM 1: Kind: Experimental
    Label: Ciclosporin A
    Description: Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
  • Injectable Saline Solution. Drug
    Intervention Desc: Saline Solution is administered once 15 min after thrombolysis.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Injectable Saline Solution.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI. at day 30 ± 15 in the T2-weighted Flair MRI. Yes
Secondary to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients. on day 1, J7, J30, J90 Yes

Sponsors