Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospices Civils de Lyon
• Treatments: Cyclosporine; Cyclosporins; Pharmaceutical Solutions

Criteria

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.