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

NCT02956200 | Withdrawn Phase 2

• 1 other identifier: YAN-2016-047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke; Inflammation

Keywords

Fingolimod Hydrochloride; Intravenous thrombolysis; Mechanical thrombectomy; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• salvaged ischemic tissue index (%)

  100\*(baseline CTP ischemic lesion (mL) - 7 day DWI infarction lesion (mL))/ baseline CTP ischemic lesion (mL)

  from baseline to 7 day

Secondary Outcomes (7)

• the growth in infarct volume (mL)

  from 24 hour to 7 day

• the penumbral salvage volume (mL)

  from baseline to 1 day

• the frequency of parenchymal hemorrhage (PH) (%)

  at day 1

• the change on the NIHSS score

  from baseline to 1 day

• the change on the NIHSS score

  from baseline to 7 day

Study Arms (2)

fingolimod with standard therapy

EXPERIMENTAL

Patients will be treated with standard alteplase bridging and mechanical thrombectomy with fingolimod.

Drug: Fingolimod

standard therapy

NO INTERVENTION

Patients will be treated with standard alteplase bridging and mechanical thrombectomy.

Interventions

Fingolimod DRUG

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 about one hour prior to mechanical thrombectomy.

Also known as: Fingolimod Hydrochloride

fingolimod with standard therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with anterior circulation acute ischaemic stroke who are eligible for alteplase and mechanical thrombectomy commenced within 6 hours of stroke onset.
• Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.
• Patient"s age is 18-85 years.
• Arterial occlusion on CTA of the ICA, M1 or M2.

You may not qualify if:

• Standard contraindications to alteplase or mechanical thrombectomy.
• Evidence of other diseases of the CNS.
• 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 (over 3 times value of normal ALS or AST).
• Concomitant use of antineoplastic, immunosuppressive or immune modulating therapies.
• Macular edema.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Shaoxing People's Hospital: collaborator
• Affiliated Hospital of Jiaxing University: collaborator
• Huzhou Center Hospital: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Jinhua Center Hospital: collaborator
• Taizhou Hospital: collaborator

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Stroke; Inflammation; Ischemic Stroke

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Min Lou, MD,PhD

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 22, 2021

Record last verified: 2016-09

Locations

CN (1)