Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

Study Overview
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Brief Summary
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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.

Official Title
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Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled

Conditions
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Stroke

Intervention / Treatment
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* Drug: Ciclosprin A
* Drug: Injectable Saline Solution.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥ 18 years and <85 years Male or female, Patients with cerebral infarction of less than 4:30H, NIHSS score between 6 and 18 Identification of a carotid artery occlusion in the territory in MRI Consent of participation signed by the patient or, if it is unable to give the family or someone you trust if it is present. Patient beneficiary of a social security system. Exclusion Criteria: Known hypersensitivity to cyclosporin A or castor oil, polyoxyethylene Patient in St. John's wort, stiripentol, bosentan or rosuvastatin History of immunosuppression recent (<6 months): cancer, lymphoma, positive serology for HIV, hepatitis, ... Known hepatic (prothrombin time <50%) Patients treated with sulfonylureas or nicorandil Patients treated with dopamine, adrenaline, noradrenaline or isoprenalin Uncontrolled hypertension defined as systolic blood pressure greater than 185mm Hg and a diastolic pressure above 110 mmHg, Cardiogenic shock defined by systolic blood pressure below 80 mm Hg Contraindication to thrombolysis: History of AIC in the three months history of intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation Presumption of septic embolism or aortic dissection or pericardial effusion. Recent biopsy or surgery within 3 months Head injury less than 3 months Known bleeding diathesis, taking anticoagulants with INR> 1.2 Hypoglycemia (blood glucose below 0.5 mmol / l) Known renal, creatinine greater than 130 Mu / L Recent Lumbar puncture <7days Conditions prior psychiatric or neurological deficit does not allow objective analysis of disability History of ischemic stroke or hemorrhagic History of epilepsy and taking antiepileptic Exclusion criteria Imaging Structured hypodensity scanner compatible with recent ischemic stroke Hematoma Other lesions (tumor or inflammatory cerebral venous thrombosis) The scanner Contraindications: allergy to iodine or major renal creatinine> 130μl or MRI referred to above Women of childbearing age, pregnant or not recognized effective contraception Patients in the measure of legal protection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciclosporin A<br>Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin) | Drug: Ciclosprin A<br>* 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<br>|
| Placebo Comparator: Placebo<br>Injectable Saline Solution. | Drug: Injectable Saline Solution.<br>* Saline Solution is administered once 15 min after thrombolysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at day 30 ± 15 in the T2-weighted Flair MRI. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | on day 1, J7, J30, J90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volume of cerebral infarction, Stroke, CsA, NIHSS