Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07509645

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke

This is an investigator-initiated phase III clinical trial employing a randomized, double-blind, placebo-controlled design. The primary objective of this study is to investigate the efficacy and safety of an interleukin-6 inhibitor (tocilizumab) combined with endovascular therapy in patients with acute posterior circulation large-vessel occlusion stroke.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suzhou Municipal Hospital, Suzhou, Anhui, China

Loading trial locations.

About this study

This is an investigator-initiated, prospective, multicenter phase III clinical trial. This trial aims to investigate whether tocilizumab could further improve prognosis for patients with acute posterior circulation large-vessel occlusion stroke receiving endovascular therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older, of either sex;
  • Acute ischemic stroke caused by occlusion of the basilar artery;
  • Decide to undergo emergency endovascular treatment;
  • Time from stroke onset to groin puncture within 24 hours;
  • National Institutes of Health Stroke Scale (NIHSS) ≥ 10;
  • Posterior circulation Alberta Stroke Program Early computed tomography score (pc-ASPECTS) ≥ 6;
  • Signed informed consent from the patients or the legally authorized representatives.

Exclusion criteria

  • Intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage;
  • Pre-stroke modified Rankin scale (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, or thrombocytopenic diseases;
  • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite blood pressure control;
  • Neutrophils < 2 × 10^9 /L;
  • Platelets < 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 >2 times the upper limit of normal;
  • Known recent or current serum creatinine >2 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 expected survival of less than 90 days;
  • Presence of autoimmune diseases or use of immunosuppressive drugs;
  • Systemic infectious diseases;
  • Participation in another interventional clinical study within 30 days before randomization or currently participating in another interventional clinical study;
  • Any circumstance that, as assessed by the investigators, might result in harm to the patients if study therapy is initiated;
  • Other conditions that the investigator considers might affect compliance or preclude participation in this study.

Treatment and study plan

Tocilizumab

Drug

240 mg of tocilizumab injection will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.

Placebo

Drug

An equivalent volume of placebo will be diluted in 0.9% NaCl to a total volume of 100 mL. The solution will be administered via intravenous infusion immediately after randomization and no later than 30 minutes, with an infusion duration of more than 1 hour.

Primary outcomes

  1. Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.

    Time frame: 90 days

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

Secondary outcomes

  1. mRS score distribution at 90 days;

    Time frame: 90 days

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

  2. Early neurological improvement at 24 hours

    Time frame: 24 hours

    Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2

  3. NIHSS score at 7 days or at early discharge

    Time frame: 7 days

    The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes

  4. Proportion of patients with mRS score 0-1 at 90 days

    Time frame: 90 days

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

  5. Proportion of patients with mRS score 0-2 at 90 days

    Time frame: 90 days

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

  6. Proportion of patients with mRS score 0-4 at 90 days

    Time frame: 90 days

    The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

  7. EQ-5D-5L at 90 days

    Time frame: 90 days

    The EQ-5D-5L comprises the same five dimensions: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION, each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems.

  8. Proportion of Barthel Index (BI) 95-100 at 90 days

    Time frame: 90 days

Other outcomes

  1. Incidence of symptomatic intracranial hemorrhage within 24 hours

    Time frame: 24 hours

  2. Incidence of any intracranial hemorrhage within 24 hours

    Time frame: 24 hours

  3. Proportion of patients with pneumonia at 7 days or at early discharge

    Time frame: 7 days

  4. Mortality at 90 days

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanjie Wu

CONTACT

[email protected]

01083199439

Xunming Ji

CONTACT

[email protected]

01083198962

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial-3

Acronym: IRIS-3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.