Fingolimod in Endovascular Treatment of Ischemic Stroke

Phase 2

• Conditions: Stroke Inflammation
• Interventions: Drug: Fingolimod

• Registration Number: NCT04629872
• Lead Sponsor: Ning Wang, MD., PhD.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-11
• Study Start: 2020-11-12
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endovascular treatment with fingolimod	Fingolimod	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China