Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciclosporin A | Experimental | Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin) |
|
| Placebo | Placebo Comparator | Injectable Saline Solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. | 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. |
| 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. | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norbert NIGHOGHOSSIAN | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69002 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25948727 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Injectable Saline Solution. | Drug | Saline Solution is administered once 15 min after thrombolysis. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |