Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment

NCT06238024 | Completed Phase 2 DMC

• 1 other identifier: SZSLYY
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Tocilizumab may exert neuroprotective effects in patients with ischemic stroke undergoing endovascular treatment

Conditions

Interleukin-6; Ischemic Stroke; Endovascular Treatment

Keywords

Acute ischemic stroke; Tocilizumab; Neuroprotection; Outcome

Outcome Measures

Primary Outcomes (1)

• Change from baseline in infarct-core volume

  The infarct-core volume is determined by diffusion-weighted MRI, CT, or CTP images.

  72 hours

Secondary Outcomes (15)

• Early neurological improvement

  within 24 hours

• NIHSS score

  24 hours

• Proportion of successful reperfusion (mTICI 2b/3)

  immediate postoperative

• Proportion of recanalization on follow-up CTA or MRA

  72 hours

• Incidence of cerebral hemorrhage

  72 hours

Other Outcomes (2)

• Change of hsCRP levels from admission to 72 hours

  72 hours

• Change of inflammatory blood biomarkers

  baseline, 24 hours, 48 hours, and 72 hours

Study Arms (2)

Tocilizumab group

EXPERIMENTAL

Intravenously for more than 1 hour.

Drug: Tocilizumab

Control group

PLACEBO COMPARATOR

Intravenously for more than 1 hour.

Drug: NaCl 0.9% 100ml

Interventions

Tocilizumab DRUG

Single dose intravenous application

Tocilizumab group

NaCl 0.9% 100ml DRUG

Single dose intravenous application

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1, or M2 segment.
• NIHSS ≥ 6.
• Meeting the criteria of endovascular treatment:
• ① ASPECTS score ≥ 6, possibile to start endovascular treatment within 6 hours from stroke onset.
• ② Stroke onset between 6-16 hours, meeting DEFUSE-3 criteria (infarct core volume \< 70ml, mismatch ratio ≥ 1.8, and mismatch volume \> 15ml), or DAWN criteria (NIHSS ≥ 10 and infarct core volume \< 31ml; or NIHSS ≥ 20 and infarct volume 31-51ml).
• ③ Stroke onset between 16-24 hours, meeting DAWN criteria (NIHSS ≥ 10 and infarct core volume \< 31ml; or NIHSS ≥ 20 and infarct volume 31-51ml).
• ④ When ASPECTS score is \< 6, meeting RESCUE-Japan LIMIT criteria (ASPECTS score 3-5; stroke onset within 6 hours or between 6-24 hours but no acute stroke signs on FLAIR), or ANGEL-ASPECT criteria (stroke onset within 24 hours, ASPECTS 3-5; or onset within 24 hours, ASPECTS 0-2 and infarct core volume 70-100 mL; or onset between 6-24 hours, ASPECTS \> 5 and infarct core volume 70-100 mL), or SELECT2 criteria (ASPECTS 3-5; or infarct core volume greater than 50ml).
• Experimental drug administration had to be possible within 24 hours after stroke onset.
• Obtained Informed consent from the patient or their legal representative.

You may not qualify if:

• Hemorrhagic diseases visible on head CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
• Pre-stroke mRS score \> 1.
• Known allergy to tocilizumab or excipients.
• Known allergy to iodinated contrast agents.
• Anticipated difficulty in completing endovascular treatment due to vascular tortuosity.
• History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc.
• Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.
• Neutrophil \< 2×10 9/L.
• Platelet \< 100×10 9/L.
• Blood glucose \< 2.8 mmol/L (50 mg/dl) or \> 22.2 mmol/L (400 mg/dl).
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal.
• Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (eGFR) \< 60 mL/min.
• Pregnant, lactating, or planning pregnancy within 90 days.
• Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia.
• Concurrent malignant tumors or severe systemic diseases with an expected survival of less than 90 days.

Sponsors & Collaborators

• Suzhou Municipal Hospital of Anhui Province: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chuanjie Wu, M.D.

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

• Zhengfei Ma, M.M.

  Suzhou Municipal Hospital of Anhui Province

  STUDY DIRECTOR

• Xunming Ji, M.D.

  Xuanwu Hospital, Beijing

  STUDY CHAIR

• Xuehong Chu, M.D.

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: February 2, 2024
• Primary Completion: June 25, 2024
• Study Completion: September 22, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)