Fingolimod in Endovascular Treatment of Ischemic Stroke

Stroke Inflammation Clinical Trial

Official title:

Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629872
• Other study ID #: MRCTA, ECFAH of FMU [2020]296
• Status: Recruiting
• Phase: Phase 2
• Start date: November 12, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: fu ying, MD
• Phone: 13920263588
• Email: fuying1995[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Ischemic Stroke
• Stroke
• Stroke Inflammation

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Ning Wang, MD., PhD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)