Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke

NCT04675762 | Recruiting Phase 2 DMC

• 1 other identifier: IMMUTAS
• Study Type: interventional
• Target: 118
• 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 AIS as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. So in this study the investigators try to determine whether the addition of fingolimod, administered within 24 hours after the onset of symptoms in patients receiving alteplase bridging with mechanical thrombectomy, improves radiologic and clinical outcomes.

Conditions

Stroke; Inflammation

Keywords

Fingolimod Hydrochloride; Intravenous thrombolysis; Mechanical thrombectomy; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%)

  mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome

  at 90 day

Secondary Outcomes (9)

• salvaged ischemic tissue index (%)

  from baseline to 7 day

• the growth in infarct volume (mL)

  from 24 hour to 7 day

• the penumbral salvage volume (mL)

  from baseline to 1 day

• the frequency of parenchymal hemorrhage (PH) (%)

  at day 1

• the change on the National Institute of Health stroke scale (NIHSS) score from baseline to 1 day

  from baseline to 1 day

Study Arms (2)

fingolimod with standard therapy

EXPERIMENTAL

Patients will be treated with standard alteplase bridging and mechanical thrombectomy with fingolimod.

Drug: Fingolimod

Placebo with standard therapy

PLACEBO COMPARATOR

Patients will be treated with standard alteplase bridging and mechanical thrombectomy with placebo.

Other: Placebo

Interventions

Fingolimod DRUG

Patients randomized to fingolimod will also receive 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 about one hour prior to mechanical thrombectomy.

fingolimod with standard therapy

Placebo OTHER

Patients randomized to fingolimod will also receive placebo once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is about one hour prior to mechanical thrombectomy.

Placebo with standard therapy

Eligibility Criteria

• Age: 18 Years - 85 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 alteplase and mechanical thrombectomy commenced within 24 hours of stroke onset or awakening with stroke (if within 24 hours from the midpoint of sleep).
• Patient's age is 18-85 years.
• Arterial occlusion on CTA of the ICA, M1 or M2.
• Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.

You may not qualify if:

• Pre-existing neurologic disability (a score greater than 2 on the mRS).
• Contraindication of fingolimod.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Shaoxing People's Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Huizhou Municipal Central Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Jinhua Center Hospital: collaborator
• Taizhou Hospital: collaborator

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke; Inflammation; Ischemic Stroke

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Min Lou, PhD, MD

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  STUDY CHAIR

Central Study Contacts

Min Lou, PhD, MD

CONTACT

13958007213; loumingxc@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 19, 2020
• Study Start: January 15, 2021
• Primary Completion: December 15, 2025
• Study Completion: March 15, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)