Neuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled|
- 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. [ Time Frame: at day 30 ± 15 in the T2-weighted Flair MRI. ] [ Designated as safety issue: Yes ]Volume of cerebral infarction at day 30 ± 15 in the T2-weighted MRI Flair will be measured by manuel contouring by two independent radiologists uninformed of clinical and therapeutic data and therapeutic
- to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients. [ Time Frame: on day 1, J7, J30, J90 ] [ Designated as safety issue: Yes ]Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Ciclosporin A
Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Drug: Ciclosprin A
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
Placebo Comparator: Placebo
Injectable Saline Solution.
Drug: Injectable Saline Solution.
Saline Solution is administered once 15 min after thrombolysis.