Stroke InflammationPhase 2NCT04629872
Fingolimod in Endovascular Treatment of Ischemic Stroke
A Phase 2 study testing Fingolimod in people with Stroke Inflammation, run by Ning Wang, MD., PhD. at 1 site in China.
Trial summary
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Inflammation
- What is being tested?
- Fingolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2020to 30 Dec 2023
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset.
- Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
- Patient's age is 18-80 years.
- Arterial occlusion on internal carotid artery proximal or middle cerebral artery
- Imaging inclusion criteria: infarct core volume between 15-70 mL
Who cannot join
- Pre-existing neurologic disability (a score greater than 2 on the mRS).
- Swallowing difficulties that would prevent administration of oral fingolimod.
- Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.
- Patients with serious acute or chronic infection, or hepatic injury
- Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
- Macular edema.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350000
Ying Fu, +8613920263688, fuying@fjmu.eu.cn
About this study
Official title: Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke
- Conditions
- Stroke Inflammation
- Being tested
- Fingolimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is more than 3 hour prior to mechanical thrombectomy.
| Study group | Role | What they receive |
|---|---|---|
| endovascular treatment with fingolimod | Experimental | Not described Receives: Drug: Fingolimod |
| endovascular treatment without fingolimod | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the grade of collateral circulation
Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary
Measured: Baseline (before endovascular treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start12 Nov 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke InflammationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ning Wang, MD., PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629872
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU [2020]296
- Status last verified
- Apr 2022
- First submitted
- 11 Nov 2020
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinating Fingolimod With Endovascular Treatment in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04629872
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU [2020]296
- Conditions
- Stroke Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ning Wang, MD., PhD.University, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Nov 2020 (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.
Proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. This study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endovascular treatment with fingolimod | Experimental | Drug: Fingolimod |
| endovascular treatment without fingolimod | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset.
- Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
- Patient's age is 18-80 years.
- Arterial occlusion on internal carotid artery proximal or middle cerebral artery
- Imaging inclusion criteria: infarct core volume between 15-70 mL
Key exclusion criteria (6 listed)
- Pre-existing neurologic disability (a score greater than 2 on the mRS).
- Swallowing difficulties that would prevent administration of oral fingolimod.
- Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.
- Patients with serious acute or chronic infection, or hepatic injury
- Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
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 |
|---|---|---|
| FingolimodPatients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is more than 3 hour prior to mechanical thrombectomy. | Drug | endovascular treatment with fingolimod |
Primary outcome
the grade of collateral circulation
Time frame: Baseline (before endovascular treatment)
Multiphasic contrast-enhanced CT collateral grades with six-point pial arterial filling ordinary score as established at the University of Calgary
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fingolimod in people with Stroke Inflammation, run by Ning Wang, MD., PhD. at 1 site in China.
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 5 inclusion and 6 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 fu ying, MD (13920263588, fuying1995@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the grade of collateral circulation (time frame: Baseline (before endovascular treatment)). 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 13 Apr 2022.