Back to resultsNeuroprotection Impact of Cyclosporin A in Cerebral Infarction (CsAStroke)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ciclosprin A
Injectable Saline Solution.
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Volume of cerebral infarction, Stroke, CsA, NIHSS
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
- 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.
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ciclosporin A
Placebo
Arm Description
Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Injectable Saline Solution.
Outcomes
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.
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.
Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01527240
Brief Title
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
Acronym
CsAStroke
Official Title
Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Volume of cerebral infarction, Stroke, CsA, NIHSS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciclosporin A
Arm Type
Experimental
Arm Description
Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injectable Saline Solution.
Intervention Type
Drug
Intervention Name(s)
Ciclosprin A
Intervention Description
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
Intervention Name(s)
Injectable Saline Solution.
Intervention Description
Saline Solution is administered once 15 min after thrombolysis.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
at day 30 ± 15 in the T2-weighted Flair MRI.
Secondary Outcome Measure Information:
Title
to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
Description
Secondary endpoints include clinical scores: NIHSS , mRS, Death, SAE (within neurological worsening of more than 4 points on the NIHSS).
Time Frame
on day 1, J7, J30, J90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert NIGHOGHOSSIAN
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25948727
Citation
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.
Results Reference
result
Learn more about this trial
Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
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