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Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke

NCT04675762 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

DRUG

Fingolimod

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Shaoxing People's Hospital

    collaborator OTHER

  • Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • Jinhua Center Hospital

    collaborator UNKNOWN

  • Taizhou Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Min Lou, PhD, MD · Second Affiliated Hospital of Zhejiang University, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2025-12-15
Completion
2026-03-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675762 on ClinicalTrials.gov