Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

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 AIS as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. So in this study the investigators try to determine whether the addition of fingolimod, administered within 24 hours after the onset of symptoms in patients receiving alteplase bridging with mechanical thrombectomy, improves radiologic and clinical outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Huzhou Center Hospital; Jiaxing People's Hospital; Jiaxing Second Hospital; Jinhua Center Hospital; Shaoxing People's Hospital; Taizhou Hospital
• Treatments: Fingolimod Hydrochloride

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.