Neuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01527240
First received: January 31, 2012
Last updated: August 27, 2013
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: Ciclosprin A
Drug: Injectable Saline Solution.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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. [ Time Frame: at day 30 ± 15 in the T2-weighted Flair MRI. ] [ Designated as safety issue: Yes ]
    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:
  • to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients. [ Time Frame: on day 1, J7, J30, J90 ] [ Designated as safety issue: Yes ]
    Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).


Estimated Enrollment: 126
Study Start Date: October 2009
Estimated Study Completion Date: January 2014
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciclosporin A
Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Drug: 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
Placebo Comparator: Placebo
Injectable Saline Solution.
Drug: Injectable Saline Solution.
Saline Solution is administered once 15 min after thrombolysis.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527240

Locations
France
Hospices Civils de Lyon
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Norbert NIGHOGHOSSIAN Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01527240     History of Changes
Other Study ID Numbers: 2008.544
Study First Received: January 31, 2012
Last Updated: August 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Volume of cerebral infarction
Stroke
CsA
NIHSS

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 22, 2014