Combining Fingolimod with Thrombectomy for Acute Ischemic Stroke
A Randomised Controlled Trial of Combinating an Immune Modulator Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke
This study is testing if adding a medication called fingolimod to standard treatments can help people aged 18 to 85 recover better from an acute ischemic stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04675762 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of fingolimod, a sphingosine-1-phosphate receptor modulator, in combination with standard treatments for acute ischemic stroke (AIS). Patients aged 18 to 85 with anterior circulation AIS will be randomly assigned to receive either fingolimod or a placebo alongside intravenous alteplase and mechanical thrombectomy. The trial aims to determine if fingolimod can improve clinical and radiologic outcomes when administered within 24 hours of symptom onset. The study will take place across multiple stroke centers in China, enrolling a total of 118 participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with anterior circulation acute ischemic stroke eligible for alteplase and mechanical thrombectomy within 24 hours of symptom onset.
Not a fit: Patients with pre-existing neurologic disabilities or contraindications to fingolimod will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and reduce brain inflammation in patients suffering from acute ischemic stroke.
How similar studies have performed: While the use of fingolimod in this context is novel, previous proof-of-concept trials have indicated potential benefits in reducing brain inflammation in stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting with anterior circulation acute ischaemic stroke who are eligible for alteplase and mechanical thrombectomy commenced within 24 hours of stroke onset or awakening with stroke (if within 24 hours from the midpoint of sleep). * Patient's age is 18-85 years. * Arterial occlusion on CTA of the ICA, M1 or M2. * Imaging inclusion criteria: infarct core volume ≤ 100 mL and penumbra ≥ 15 mL with at least 20% mismatch (as evaluated by CTP). * Patient, family member or legally responsible person depending on local ethics requirements has given informed consent. Exclusion Criteria: * Pre-existing neurologic disability (a score greater than 2 on the mRS). * Contraindication of fingolimod.
Where this trial is running
Hangzhou, Zhejiang
- The second affiliated hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Min Lou, PhD, MD
- Email: loumingxc@vip.sina.com
- Phone: 13958007213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.