Neuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)
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|ClinicalTrials.gov Identifier: NCT01527240|
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : May 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Ciclosprin A Drug: Injectable Saline Solution.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2013|
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.
- 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. ]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 ]Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527240
|Hospices Civils de Lyon|
|Lyon, France, 69002|
|Principal Investigator:||Norbert NIGHOGHOSSIAN||Hospices Civils de Lyon|