StrokeREPAIR FASTNCT04718064
Revascularization Pretreated With Fingolimod in Acute Stroke
A study testing Fingolimod in people with Stroke, run by The Affiliated Hospital of Xuzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Fingolimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Fingolimod, placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days
placeboDrug
placebo once daily, for three consecutive days,
| Study group | Role | What they receive |
|---|---|---|
| fingolimod with standard therapy | Experimental | Patients will be treated with intravascular therapy and fingomod. Receives: Drug: Fingolimod |
| Placebo with standard therapy | Placebo comparator | Patients will be treated with intravascular therapy and placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day mRS score
recovery
Measured: at day 90
Secondary outcomes (8)
mRS score of 0-1 (%)
excellent recovery
Measured: at day 90
mRS score of 1-2 (%)
general recovery
Measured: at day 90
Recanalization success rate
baseline mTICI score - 2 day mTICIS score
Measured: from baseline to 2 day
the growth in infarct volume (mL)
24 hour DWI infarct volume (mL) - 7 day FLAIR infarct volume (mL)
Measured: from 24 hour to 7 day
the penumbral salvage volume (mL)
baseline CTP hypoperfusion volume (mL) - 24 hour DWI infarct volume (mL)
Measured: from baseline to 1 day
the change on the NIHSS score
baseline NIHSS score - 1 day NIHSS score
Measured: 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
Measured: from baseline to 7 day
the change on the EQ-5D score
baseline EQ-5D score - 90 day EQ-5D score
Measured: from baseline to 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718064
- Sponsor's protocol ID
- XYFY00001
- Acronym
- REPAIR FAST
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization Pretreated With Fingolimod in Acute Stroke
- ClinicalTrials.gov ID
- NCT04718064
- Acronym / sponsor ID
- REPAIR FAST / XYFY00001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fingolimod with standard therapy | Experimental | Drug: FingolimodPatients will be treated with intravascular therapy and fingomod. |
| Placebo with standard therapy | Placebo comparator | Drug: placeboPatients will be treated with intravascular therapy and placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingolimodfingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days | Drug | fingolimod with standard therapy |
| placeboplacebo once daily, for three consecutive days, | Drug | Placebo with standard therapy |
Primary outcome
90 day mRS score
Time frame: at day 90
recovery
8 secondary outcomes
mRS score of 0-1 (%)
Time frame: at day 90
mRS score of 1-2 (%)
Time frame: at day 90
Recanalization success rate
Time frame: from baseline to 2 day
the growth in infarct volume (mL)
Time frame: from 24 hour to 7 day
the penumbral salvage volume (mL)
Time frame: from baseline to 1 day
the change on the NIHSS score
Time frame: from baseline to 1 day
the change on the NIHSS score
Time frame: from baseline to 7 day
the change on the EQ-5D score
Time frame: from baseline to 90 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Fingolimod in people with Stroke, run by The Affiliated Hospital of Xuzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Xinchun (+8615996999283, lzh316@vip.qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 day mRS score (time frame: at day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.