Hospices Civils de Lyon
Lyon, 69002, France
NCT Number: NCT01527240
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Lyon, 69002, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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).
Hospices Civils de Lyon
Other
Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
Acronym: CsAStroke
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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