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Completed

NCT Number: NCT01527240

Neuroprotection Impact of Cyclosporin A in Cerebral Infarction

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciclosprin A

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

Injectable Saline Solution.

Drug

Saline Solution is administered once 15 min after thrombolysis.

Primary outcomes

  1. 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.

    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 outcomes

  1. 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

    Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled

Acronym: CsAStroke

Important dates

Study start
2009
Primary completion
2009
Study completion
2013
First posted
Feb 6, 2012
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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