Clinical trial NCT01527240: Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
Official title: Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Volume of cerebral infarction
Stroke
CsA
NIHSS
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: at day 30 ± 15 in the T2-weighted Flair MRI.
Secondary outcomes:
measure: to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
timeFrame: on day 1, J7, J30, J90
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Norbert NIGHOGHOSSIAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nighoghossian N, Berthezene Y, Mechtouff L, Derex L, Cho TH, Ritzenthaler T, Rheims S, Chauveau F, Bejot Y, Jacquin A, Giroud M, Ricolfi F, Philippeau F, Lamy C, Turc G, Bodiguel E, Domigo V, Guiraud V, Mas JL, Oppenheim C, Amarenco P, Cakmak S, Sevin-Allouet M, Guillon B, Desal H, Hosseini H, Sibon I, Mahagne MH, Ong E, Mewton N, Ovize M. Cyclosporine in acute ischemic stroke. Neurology. 2015 Jun 2;84(22):2216-23. doi: 10.1212/WNL.0000000000001639. Epub 2015 May 6.