Acute ischemic stroke
Conditions
Interventions
Fingolimoid Group:Fingolimod capsule 0.5mg/day for 3 consecutive days
Placebo Group:Placebo capsule 0.5mg/day for 3 consecutive days
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 to 100 years; 2) 4 = 3; 4) Acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery or M1/proximal M2 segments of the middle cerebral artery), confirmed by CTA/MRA/DSA within 24 hours of onset, and plan to receive endovascular treatment 5) The patient or their legal representative voluntarily signs the informed consent approved by the ethics committ.
Exclusion criteria
Exclusion criteria: 1) Suffering from terminal illness with a life expectancy of 2 before onset; 3) History of intracranial hemorrhagic disease within the past 3 months, including substantial hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.; 4) Severe liver or kidney dysfunction (severe liver dysfunction is defined as ALT or AST > 3 times the upper limit of normal; severe kidney dysfunction is defined as serum creatinine > 3.0 mg/dL [265.2 µmol/L] or glomerular filtration rate 22.2 mmol/L, or platelets = 500 ms on electrocardiogram; 7) Currently taking medications that may slow heart rate or atrioventricular (AV) conduction and cannot safely discontinue them as per the protocol requirements before administration; 8) History of or currently using anti-tumor, immunosuppressive, or immunomodulatory drugs; 9) Presence of active severe infection (e.g., active hepatitis B/C, active tuberculosis, HIV infection, or other systemic infections requiring systemic treatment); 10) Known allergy to fingolimod or any of its excipients; 11) Pregnant or breastfeeding women, or women of childbearing age not using effective contraception; 12) Participation in or currently involved in another clinical trial that may affect the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale Score at 90 days;Death within 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale Score of 0 to 1 at 90 days;Modified Rankin Scale Score of 0 to 2 at 90 days;Modified Rankin Scale Score of 0 to 3 at 90 days;Modified Rankin Scale Score of 0 to 4 at 90 days;Change in NIHSS score from baseline at 5-7 d or dischargeif earlier;Incidence of sICH;Incidence of non hemorrhagic serious adverse events;Systemic Bleeding; | — |
Countries
China
Contacts
Public ContactYang Qingwu
The Second Affiliated Hospital of Army Medical University
Outcome results
None listed