Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

NCT ID: NCT01527240

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ciclosporin A

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

Group Type: EXPERIMENTAL

Ciclosprin A

Intervention Type: DRUG

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

Placebo

Injectable Saline Solution.

Group Type: PLACEBO_COMPARATOR

Injectable Saline Solution.

Intervention Type: DRUG

Saline Solution is administered once 15 min after thrombolysis.

Interventions

Ciclosprin 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

Intervention Type: DRUG

Injectable Saline Solution.

Saline Solution is administered once 15 min after thrombolysis.

Intervention Type: DRUG

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norbert NIGHOGHOSSIAN

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon

Lyon, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 25948727 (View on PubMed)

Other Identifiers

2008.544

Identifier Type: -

Identifier Source: org_study_id