Fingolimod in Endovascular Treatment of Ischemic Stroke

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ning Wang, MD., PhD.
• Treatments: Fingolimod Hydrochloride

Criteria

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.