Revascularization Pretreated With Fingolimod in Acute Stroke

NCT ID: NCT04718064

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-01-31

Brief 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

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

fingolimod with standard therapy

Patients will be treated with intravascular therapy and fingomod.

Group Type: EXPERIMENTAL

Fingolimod

Intervention Type: DRUG

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

Placebo with standard therapy

Patients will be treated with intravascular therapy and placebo.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo once daily, for three consecutive days,

Interventions

Fingolimod

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

Intervention Type: DRUG

placebo

placebo once daily, for three consecutive days,

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient was over 18 years old;
• The NIHSS score was < 30 and NIHSS > 5;
• CTA / MRA / DSA confirmed occlusion of M1 segment of internal carotid artery or middle cerebral artery, and aspect score ≥ 6;
• CTP or MRI showed mismatch (ischemic core volume < 70ml, CTP mismatch > 1.2
• Normal to random time within 24 hours
• Written informed consent signed by patients or their families

Exclusion Criteria

• Standard contraindications to alteplase or mechanical thrombectomy
• Cerebral hemorrhage confirmed by imaging
• Cardiovascular diseases (such as bradycardia, etc.)
• Systolic blood pressure > 185mmhg or diastolic blood pressure > 110mmhg, and oral antihypertensive drugs can not be controlled
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ye Xinchun

Role: CONTACT

lzh316@vip.qq.com

+8615996999283

Other Identifiers

XYFY00001

Identifier Type: -

Identifier Source: org_study_id