Fingolimod in Endovascular Treatment of Ischemic Stroke | NCT04629872

Studies
Fingolimod in Endovascular Treatment of Ischemic Stroke

NCT04629872

Sponsor

Ning Wang, MD., PhD.

Status

Unknown status

Last Update Posted

Apr 13, 2022Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Stroke Inflammation

Interventions

Fingolimod

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 12, 2020Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Nov 11, 2020

First Submission Date that Met QC Criteria

Nov 13, 2020

First Posted Date

Nov 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2022

Last Update Posted Date

Apr 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ning Wang, MD., PhD., Director of Neurology department, First Affiliated Hospital of Fujian Medical UniversitySponsor-Investigator

Lead Sponsor

Ning Wang, MD., PhD.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
endovascular treatment with fingolimod	Experimental		Drug: Fingolimod
endovascular treatment without fingolimod	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
fu ying, MD	Contact	13920263588		fuying1995@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Fujian Medical University	Recruiting	Fuzhou		350000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068876	Fingolimod Hydrochloride

Ancestor Terms

ID	Term
D013110	Sphingosine
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

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Browse Branches

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