Clinical trial NCT02002390: Efficacy and Safety of FTY720 for Acute Stroke
Official title: Efficacy and Safety of FTY720 for the Treatment of Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Vascular Accident
Cerebral Stroke
Ischemic Cerebrovascular Accident
Stroke, Acute
Keywords: Stroke,Fingolimod(FTY 720), treatment
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Clinical presentation of spontaneous intracerebral hemorrhage/ischemic stroke
* MRI/MRA scan compatible with spontaneous intracerebral hemorrhage/ ischemic stroke
* Time to fty720 treatment\< 72 h from symptom onset
* Glasgow Coma Score \>6 on initial presentation or improvement to a Glasgow Coma Score \>6 within the time frame for enrollment.
* Primary supratentorial ICH of ≥5cc and \<30cc
* TOAST: Large-artery atherosclerosis

Exclusion Criteria:

* Patients who will undergo surgical evacuation of intracerebral hemorrhage
* Inability to undergo neuroimaging with Magnetic Resonance
* Glasgow Coma Score \< 6.
* Baseline modified Rankin Scale score \>1
* Primary intraventricular hemorrhage ICH due to coagulopathy (PT \> 15 s or International Normalized Ratio \> 1.3, Partial Thromboplastin Time \> 36) or trauma
* Thrombocytopenia: platelet count \<100 000
* Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs \>2x normal, coagulopathy as described)
* Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
* Pregnancy
* Malignancy (history of or active)
* Bradyarrhythmia and Atrioventricular Block
* Concomitant use with antineoplastic,immunosuppressive or immune modulating therapies
* Macular Edema

Primary outcomes:
measure: Clinical improvement
timeFrame: up to 90 days
Secondary outcomes:
measure: Change in image
timeFrame: up to 90 days
measure: Change in immunology function
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Fu-Dong Shi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.