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

Phase 2

Active, not recruiting

• Conditions: Interleukin-6; Ischemic Stroke; Endovascular Treatment
• Interventions: Drug: Tocilizumab; Drug: NaCl 0.9% 100ml

• Registration Number: NCT06238024
• Lead Sponsor: Suzhou Municipal Hospital of Anhui Province

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.

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-24
• Study Start: 2024-02-02
• Study First Posted: 2024-02-02
• Primary Completion: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Completion: 2024-09-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocilizumab group	Tocilizumab	Intravenously for more than 1 hour.
Control group	NaCl 0.9% 100ml	Intravenously for more than 1 hour.

Primary Outcome Measures

Name	Time	Method
Change from baseline in infarct-core volume	72 hours	The infarct-core volume is determined by diffusion-weighted MRI, CT, or CTP images.

Secondary Outcome Measures

Name	Time	Method
Incidence of stroke-associated pneumonia	7 days
Death	90 days
Early neurological improvement	within 24 hours	Decrease in National Institute of Health stroke scale (NIHSS) score of ≥8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Proportion of recanalization on follow-up CTA or MRA	72 hours
Proportion of patients with functional independence (mRS 0-2)	90 days	Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability
NIHSS score	7 days	National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit
Incidence of cerebral hemorrhage	72 hours
Adverse events and serious adverse events	90 days
Incidence of symptomatic cerebral hemorrhage	72 hours
Barthel Index	90 days	The Barthel index is an ordinal scale for measuring performance of activities of daily living. Scores ranges from 0 to 20, with 0 indicating severe disability and 19 or 20 indicating no disability that interferes with daily activities.
EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D)	90 days	EQ-5D is a standardized instrument for the measurement of health status. Scores range from -0.33 to 1.00, with higher scores indicating a better quality of life
Proportion of successful reperfusion (mTICI 2b/3)	immediate postoperative	mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow)
Incidence of decompressive craniectomy	7 days
Shift analysis of mRS score	90 days	Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability

Trial Locations

Locations (1)

Suzhou Municipal Hospital of Anhui Province; 🇨🇳 Suzhou, Anhui, China