Revascularization Pretreated With Fingolimod in Acute Stroke

NCT04718064 | Unknown

• 1 other identifier: XYFY00001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 90 day mRS score

  recovery

  at day 90

Secondary Outcomes (8)

• mRS score of 0-1 (%)

  at day 90

• mRS score of 1-2 (%)

  at day 90

• Recanalization success rate

  from baseline to 2 day

• the growth in infarct volume (mL)

  from 24 hour to 7 day

• the penumbral salvage volume (mL)

  from baseline to 1 day

Study Arms (2)

fingolimod with standard therapy

EXPERIMENTAL

Patients will be treated with intravascular therapy and fingomod.

Drug: Fingolimod

Placebo with standard therapy

PLACEBO COMPARATOR

Patients will be treated with intravascular therapy and placebo.

Drug: placebo

Interventions

Fingolimod DRUG

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

fingolimod with standard therapy

placebo DRUG

placebo once daily, for three consecutive days,

Placebo with standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

MeSH Terms

Conditions

Stroke

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ye Xinchun

CONTACT

+8615996999283; lzh316@vip.qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: January 31, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share