Stroke Inflammation
Conditions
Brief summary
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke
Interventions
DRUGFingolimod
Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is more than 3 hour prior to mechanical thrombectomy.
Sponsors
Ning Wang, MD., PhD.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset. * Patient, family member or legally responsible person depending on local ethics requirements has given informed consent. * Patient's age is 18-80 years. * Arterial occlusion on internal carotid artery proximal or middle cerebral artery * Imaging inclusion criteria: infarct core volume between 15-70 mL
Exclusion criteria
* Pre-existing neurologic disability (a score greater than 2 on the mRS). * Swallowing difficulties that would prevent administration of oral fingolimod. * Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil. * Patients with serious acute or chronic infection, or hepatic injury * Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies. * Macular edema.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the grade of collateral circulation | Baseline (before endovascular treatment) | Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary |
Countries
China
Contacts
Primary Contactfu ying, MD
Outcome results
None listed