Neuroprotection Impact of Cyclosporin A in Cerebral Infarction
CsAStroke
Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
1 other identifier
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 stroke
Started Oct 2009
Longer than P75 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 6, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 28, 2019
January 1, 2012
Same day
January 31, 2012
May 23, 2019
Conditions
Keywords
Outcome Measures
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.
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 Outcomes (1)
to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.
on day 1, J7, J30, J90
Study Arms (2)
Ciclosporin A
EXPERIMENTALInjection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
Placebo
PLACEBO COMPARATORInjectable Saline Solution.
Interventions
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
Saline Solution is administered once 15 min after thrombolysis.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69002, France
Related Publications (1)
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.
PMID: 25948727RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norbert NIGHOGHOSSIAN
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 6, 2012
Study Start
October 1, 2009
Primary Completion
October 1, 2009
Study Completion
December 1, 2013
Last Updated
May 28, 2019
Record last verified: 2012-01