Status:
COMPLETED
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01527240
Start Date
October 1 2009
End Date
December 1 2013
Last Update
May 28 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospices Civils de Lyon
Lyon, France, 69002