Fingolimod in Endovascular Treatment of Ischemic Stroke

Sponsor

Ning Wang, MD., PhD. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04629872

Collaborator

(none)

Enrollment

Location

Arms

37.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Inflammation	Drug: Fingolimod	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke

Actual Study Start Date :

Nov 12, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endovascular treatment with fingolimod	Drug: Fingolimod 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.
No Intervention: endovascular treatment without fingolimod

Arm

Intervention/Treatment

Experimental: endovascular treatment with fingolimod

Drug: Fingolimod

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.

No Intervention: endovascular treatment without fingolimod

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Fujian Medical University	Fuzhou		China	350000

Sponsors and Collaborators

Ning Wang, MD., PhD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ning Wang, MD., PhD., Director of Neurology department, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT04629872

Other Study ID Numbers:

MRCTA, ECFAH of FMU [2020]296

First Posted:

Nov 16, 2020

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Inflammation

Fingolimod Hydrochloride

Study Results

No Results Posted as of Apr 13, 2022