Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

Phase 2

Completed

• Conditions: Stroke
• Interventions: Drug: Ciclosprin A; Drug: Injectable Saline Solution.

• Registration Number: NCT01527240
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-06
• Study Completion: 2013-12
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciclosporin A	Ciclosprin A	Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Placebo	Injectable Saline Solution.	Injectable Saline Solution.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France