Neuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)

Civil Hospices of Lyon

Status and phase: Completed; Phase 2

Conditions: Stroke

Treatments: Drug: Injectable Saline Solution.; Drug: Ciclosprin A

Study type: Interventional

Funder types: Other

Identifiers

NCT01527240

2008.544

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

126 participants in 2 patient groups, including a placebo group

Ciclosporin A

Experimental group

Description:

Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)

Treatment:

Drug: Ciclosprin A

Placebo

Placebo Comparator group

Description:

Injectable Saline Solution.

Treatment:

Drug: Injectable Saline Solution.