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

NCT ID: NCT06238024

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-09-22

Brief Summary

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

Detailed Description

Vascular recanalization techniques, including thrombolysis and thrombectomy, have become the mainstay of treatment for acute ischemic stroke. However, some patients still experience poor prognosis, with ineffective recanalization and reperfusion brain injury being the major contributors to unfavorable outcomes. Studies have indicated that tocilizumab, used in ST-segment elevation and non-ST-segment elevation myocardial infarction, exhibits anti-inflammatory and myocardial protective effects. Nevertheless, whether tocilizumab can provide neuroprotection in the early stages of acute large vessel recanalization remains uncertain. Given the above evidence, the aim of this study was to investigate whether combination therapy with tocilizumab in the early phase of recanalization of acute large vessel occlusion could further exert a beneficial effect and thus improve the poor prognosis of patients.

Conditions

Interleukin-6; Ischemic Stroke; Endovascular Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tocilizumab group

Intravenously for more than 1 hour.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Single dose intravenous application

Control group

Intravenously for more than 1 hour.

Group Type: PLACEBO_COMPARATOR

NaCl 0.9% 100ml

Intervention Type: DRUG

Single dose intravenous application

Interventions

Tocilizumab

Single dose intravenous application

Intervention Type: DRUG

NaCl 0.9% 100ml

Single dose intravenous application

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years.

2. Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1, or M2 segment.

3. NIHSS ≥ 6.

4. 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).

5. Experimental drug administration had to be possible within 24 hours after stroke onset.

6. Obtained Informed consent from the patient or their legal representative.

Exclusion Criteria

1. Hemorrhagic diseases visible on head CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.

2. Pre-stroke mRS score > 1.

3. Known allergy to tocilizumab or excipients.

4. Known allergy to iodinated contrast agents.

5. Anticipated difficulty in completing endovascular treatment due to vascular tortuosity.

6. History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc.

7. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.

8. Neutrophil < 2×10 9/L.

9. Platelet < 100×10 9/L.

10. Blood glucose < 2.8 mmol/L (50 mg/dl) or > 22.2 mmol/L (400 mg/dl).

11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal.

12. Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (eGFR) < 60 mL/min.

13. Pregnant, lactating, or planning pregnancy within 90 days.

14. Severe mental disorders or inability to comply with informed consent and follow-up requirements due to dementia.

15. Concurrent malignant tumors or severe systemic diseases with an expected survival of less than 90 days.

16. Presence of autoimmune diseases or use of immunosuppressive drugs.

17. Systemic infectious diseases

18. Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Suzhou Municipal Hospital of Anhui Province

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chuanjie Wu, M.D.

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Zhengfei Ma, M.M.

Role: STUDY_DIRECTOR

Suzhou Municipal Hospital of Anhui Province

Xunming Ji, M.D.

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Xuehong Chu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

Countries

China

Other Identifiers

SZSLYY

Identifier Type: -

Identifier Source: org_study_id