MedTrace Logo

Revascularization Pretreated With Fingolimod in Acute Stroke

NCT04718064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-22

No results posted yet for this study

Summary

Acute ischemic stroke (AIS) is a common type of stroke in the elderly. Timely blood flow recovery can effectively improve the long-term prognosis of patients. According to five large-scale multicenter randomized controlled trials (MR clean, swift-prime, revascat, escape and extend-ia) in recent years, the effect of endovascular therapy (EVT) for acute anterior circulation occlusion of great vessels is significantly better than that of drug therapy alone. Therefore, for patients who meet the "Chinese guidelines for the diagnosis and treatment of acute ischemic stroke" (2018 Edition), the effect of EVT is better than that of drug therapy alone, Intravenous thrombolysis within 4.5 hours and endovascular mechanical thrombectomy within 6 hours can effectively relieve the clinical symptoms and reduce the mortality of AIS. However, due to the narrow application time window of intravenous thrombolysis and mechanical thrombectomy, although the thrombectomy time window of some eligible patients was relaxed to 24 hours after dawn and defuse3 and other related studies, the reperfusion injury after the blocked cerebral artery recanalization has brought huge obstacles to clinical application. Therefore, how to improve the prognosis of patients with endovascular therapy has become a hot research direction.

Fingomod is a kind of sphingosine analogues acting on sphingosine-1-phosphate (sipr). After phosphorylation in the body, fingomod combines with lymphocyte SIP receptor, changes lymphocyte migration route, prevents it from entering the area outside the lymphoid tissue, so as to avoid its infiltration into the central nervous system and achieve immunosuppression. Currently, it is the first-line disease modifying oral drug for multiple sclerosis. Fingolmod shows neuroprotective effects on many central nervous system diseases including cerebral ischemia. Fingomod not only reduced the number of lymphocytes invading the brain, but also decreased the number of lymphocytes in the microcirculation system

Conditions

Interventions

DRUG

Fingolimod

fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days

DRUG

placebo

placebo once daily, for three consecutive days,

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-10-31
Completion
2022-01-31

More Related Trials

Entities

Drugs
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 NCT04718064 on ClinicalTrials.gov