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Revascularization Pretreated With Fingolimod in Acute Stroke (REPAIR FAST)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fingolimod
placebo
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    fingolimod with standard therapy

    Placebo with standard therapy

    Arm Description

    Patients will be treated with intravascular therapy and fingomod.

    Patients will be treated with intravascular therapy and placebo.

    Outcomes

    Primary Outcome Measures

    90 day mRS score
    recovery

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 17, 2021
    Last Updated
    January 17, 2021
    Sponsor
    The Affiliated Hospital of Xuzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04718064
    Brief Title
    Revascularization Pretreated With Fingolimod in Acute Stroke
    Acronym
    REPAIR FAST
    Official Title
    Revascularization Pretreated With Fingolimod in Acute Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Affiliated Hospital of Xuzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    fingolimod with standard therapy
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with intravascular therapy and fingomod.
    Arm Title
    Placebo with standard therapy
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be treated with intravascular therapy and placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Fingolimod
    Intervention Description
    fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo once daily, for three consecutive days,
    Primary Outcome Measure Information:
    Title
    90 day mRS score
    Description
    recovery
    Time Frame
    at day 90
    Secondary Outcome Measure Information:
    Title
    mRS score of 0-1 (%)
    Description
    excellent recovery
    Time Frame
    at day 90
    Title
    mRS score of 1-2 (%)
    Description
    general recovery
    Time Frame
    at day 90
    Title
    Recanalization success rate
    Description
    baseline mTICI score - 2 day mTICIS score
    Time Frame
    from baseline to 2 day
    Title
    the growth in infarct volume (mL)
    Description
    24 hour DWI infarct volume (mL) - 7 day FLAIR infarct volume (mL)
    Time Frame
    from 24 hour to 7 day
    Title
    the penumbral salvage volume (mL)
    Description
    baseline CTP hypoperfusion volume (mL) - 24 hour DWI infarct volume (mL)
    Time Frame
    from baseline to 1 day
    Title
    the change on the NIHSS score
    Description
    baseline NIHSS score - 1 day NIHSS score
    Time Frame
    from baseline to 1 day
    Title
    the change on the NIHSS score
    Description
    baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score baseline NIHSS score - 7 day NIHSS score
    Time Frame
    from baseline to 7 day
    Title
    the change on the EQ-5D score
    Description
    baseline EQ-5D score - 90 day EQ-5D score
    Time Frame
    from baseline to 90 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ye Xinchun
    Phone
    +8615996999283
    Email
    lzh316@vip.qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Revascularization Pretreated With Fingolimod in Acute Stroke

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