Stroke
Conditions
Keywords
Volume of cerebral infarction, Stroke, CsA, NIHSS
Brief summary
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.
Interventions
DRUGCiclosprin 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
DRUGInjectable Saline Solution.
Saline Solution is administered once 15 min after thrombolysis.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients. | 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). |
Countries
France
Outcome results
None listed