Fingolimod in Endovascular Treatment of Ischemic Stroke

NCT04629872 | Unknown Phase 2

• 1 other identifier: MRCTA, ECFAH of FMU [2020]296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke Inflammation

Outcome Measures

Primary Outcomes (1)

• the grade of collateral circulation

  Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary

  Baseline (before endovascular treatment)

Study Arms (2)

endovascular treatment with fingolimod

EXPERIMENTAL

Drug: Fingolimod

endovascular treatment without fingolimod

NO INTERVENTION

Interventions

Fingolimod DRUG

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.

endovascular treatment with fingolimod

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ning Wang, MD., PhD.: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350000, China

RECRUITING

MeSH Terms

Interventions

Fingolimod Hydrochloride

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Central Study Contacts

fu ying, MD

CONTACT

13920263588; fuying1995@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neurology department

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 16, 2020
• Study Start: November 12, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)