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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
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
Saline Solution is administered once 15 min after thrombolysis.
Hospices Civils de Lyon
Lyon, France
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.
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
Time frame: at day 30 ± 15 in the T2-weighted Flair MRI.
to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
Time frame: on day 1, J7, J30, J90
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