Revascularization Pretreated With Fingolimod in Acute Stroke (REPAIR FAST)

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Drug: Fingolimod; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fingolimod with standard therapy; Patients will be treated with intravascular therapy and fingomod.	Drug: Fingolimod; fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days
Placebo Comparator: Placebo with standard therapy; Patients will be treated with intravascular therapy and placebo.	Drug: placebo; placebo once daily, for three consecutive days,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 day mRS score	recovery	at day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS score of 0-1 (%)	excellent recovery	at day 90
mRS score of 1-2 (%)	general recovery	at day 90
Recanalization success rate	baseline mTICI score - 2 day mTICIS score	from baseline to 2 day
the growth in infarct volume (mL)	24 hour DWI infarct volume (mL) - 7 day FLAIR infarct volume (mL)	from 24 hour to 7 day
the penumbral salvage volume (mL)	baseline CTP hypoperfusion volume (mL) - 24 hour DWI infarct volume (mL)	from baseline to 1 day
the change on the NIHSS score	baseline NIHSS score - 1 day NIHSS score	from baseline to 1 day
the change on the NIHSS score	baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score	from baseline to 7 day
the change on the EQ-5D score	baseline EQ-5D score - 90 day EQ-5D score	from baseline to 90 day

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: January 17, 2021
• First Submitted That Met QC Criteria: January 17, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: XYFY00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No