Combinating Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke

• Status: Withdrawn
• Trial end date: 2018-12-01
• 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 6 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; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Patients presenting with anterior circulation acute ischaemic stroke who are eligible for alteplase and mechanical thrombectomy commenced within 6 hours of stroke onset.

2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.

3. Patient"s age is 18-85 years.

4. Arterial occlusion on CTA of the ICA, M1 or M2.

5. Imaging inclusion criteria: infarct core volume between 15-100 mL with at least 20% mismatch (as evaluated by CTP).

Exclusion Criteria:

1. Standard contraindications to alteplase or mechanical thrombectomy.

2. Evidence of other diseases of the CNS.

3. Pre-existing neurologic disability (a score greater than 2 on the mRS).

4. Swallowing difficulties that would prevent administration of oral fingolimod.

5. Patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil.

6. Patients with serious acute or chronic infection, or hepatic injury (over 3 times value of normal ALS or AST).

7. Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.

8. Macular edema.