Back to resultsFingolimod in Endovascular Treatment of Ischemic Stroke
Primary Purpose
Stroke Inflammation
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fingolimod
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Inflammation
Eligibility 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.
Sites / Locations
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
endovascular treatment with fingolimod
endovascular treatment without fingolimod
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04629872
Brief Title
Fingolimod in Endovascular Treatment of Ischemic Stroke
Official Title
Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ning Wang, MD., PhD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endovascular treatment with fingolimod
Arm Type
Experimental
Arm Title
endovascular treatment without fingolimod
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Description
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.
Primary Outcome Measure Information:
Title
the grade of collateral circulation
Description
Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary
Time Frame
Baseline (before endovascular treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fu ying, MD
Phone
13920263588
Email
fuying1995@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Fu
Phone
+8613920263688
Email
fuying@fjmu.eu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fingolimod in Endovascular Treatment of Ischemic Stroke
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