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Stroke is one of the main severe disease of public health importance. Increasing evidence suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator Fingolimod(FTY720)is an effective immunology modulator which has been widely used in autoimmune disease and has been testified effective on stoke animal models.
This study will enroll 87 stroke patients who have been diagnosed with stroke and meet the inclusion criteria.
After successfully meeting initial screening criteria, investigators will contact the family, explain the study, and send a consent form for their review.
After that, patients will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days , then investigators will make a neurofunctional assessment before and 7days, 30 days and 90days after oral fingolimod. And Magnetic Resonance of the brain before, 7days, 14days and 90days after oral fingolimod. Furthermore 5ml intravenous blood for flow cytometry is also taken before and 1day,3days,7days after fingolimod use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod (FTY720) group | Experimental | Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset. |
|
| Control group | Placebo Comparator | Patients will receive usual care and drug use in hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | A sphingosine-1-phosphate receptor regulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale are used to describe the clinical improvement at baseline, 7days, 14days, 30days and 90days. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in image | Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset | up to 90 days |
| Change in immunology function | Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fu-Dong Shi, MD,PhD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35720286 | Derived | Li HD, Li R, Kong Y, Zhang W, Qi C, Wang D, Hao H, Liu Q. Selective Sphingosine 1-Phosphate Receptor 1 Modulation Augments Thrombolysis of Low-Dose Tissue Plasminogen Activator Following Cerebrovascular Thrombosis. Front Immunol. 2022 May 27;13:801727. doi: 10.3389/fimmu.2022.801727. eCollection 2022. | |
| 26202811 | Derived |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| up to 7 days |
| Zhu Z, Fu Y, Tian D, Sun N, Han W, Chang G, Dong Y, Xu X, Liu Q, Huang D, Shi FD. Combination of the Immune Modulator Fingolimod With Alteplase in Acute Ischemic Stroke: A Pilot Trial. Circulation. 2015 Sep 22;132(12):1104-1112. doi: 10.1161/CIRCULATIONAHA.115.016371. Epub 2015 Jul 22. |
| 25003359 | Derived | Fu Y, Hao J, Zhang N, Ren L, Sun N, Li YJ, Yan Y, Huang D, Yu C, Shi FD. Fingolimod for the treatment of intracerebral hemorrhage: a 2-arm proof-of-concept study. JAMA Neurol. 2014 Sep;71(9):1092-101. doi: 10.1001/jamaneurol.2014.1065. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |