Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2 (IRIS-2)

Capital Medical University

Status and phase: Enrolling; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07263776

IRIS-2

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.

Full description

The study population are patients with acute anterior circulation large vessel occlusion stroke and planned to undergo endovascular treatment. All participants are randomly assigned in a 1:1 ratio to the tocilizumab group or the placebo group. In tocilizumab group, participants will receive tocilizumab combined endovascular treatment. And in placebo group, participants will receive placebo combined endovascular treatment. All participants will be visited immediately postoperatively, at 24 hours, 7 days, and 90 days after randomization.

Enrollment: 692 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or greater, male or female;
2. Acute ischemic stroke caused by occlusion of intracranial segment of the internal carotid artery, middle cerebral artery M1 or proximal/dominant M2 segment;
3. Decided to undergo emergency endovascular treatment;
4. Time from stroke onset to arterial puncture within 24 hours;
5. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
6. Signed informed consent from the patients or the legally authorized representatives.

Exclusion criteria

1. Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
2. Pre-stroke modified Rankin scale (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, or thrombocytopenic diseases;
7. Systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite blood pressure control;
8. Neutrophils <2×109 /L;
9. Platelets <100×109 /L;
10. Blood glucose <2.8mmol/L (50 mg/dL) or >22.2mmol/L (400 mg/dL);
11. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2 times the upper limit of normal;
12. Known recent or current serum creatinine >2 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 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;
19. Considered by the investigator to have other conditions that might affect compliance or preclude participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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692 participants in 2 patient groups, including a placebo group

Tocilizumab group

Experimental group

Description:

Endovascular treatment combined 240 mg tocilizumab injection once.

Treatment:

Drug: Tocilizumab

Placebo group

Placebo Comparator group

Description:

Endovascular treatment combined equivalent volume of placebo once.

Treatment:

Drug: Placebo