Status:
RECRUITING
Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Shaoxing People's Hospital
Affiliated Hospital of Jiaxing University
Conditions:
Stroke
Inflammation
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 p...
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled design clinical trial, in multiple stroke centers of China. The total sample size will be 118. Patients being treated with standard ...
Eligibility Criteria
Inclusion
- 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
- Pre-existing neurologic disability (a score greater than 2 on the mRS).
- Contraindication of fingolimod.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04675762
Start Date
January 15 2021
End Date
March 15 2026
Last Update
April 18 2023
Active Locations (1)
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1
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310009