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

About this trial
This is an interventional treatment trial for Stroke
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
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
NCT ID
NCT04718064
First Posted
January 17, 2021
Last Updated
January 17, 2021
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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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