Neuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)

May 23, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69002
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at day 30 ± 15 in the T2-weighted Flair MRI.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
on day 1, J7, J30, J90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimate)

February 6, 2012

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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