A Phase 3 interventional study of Tocilizumab and Placebo in Ischemic Stroke, sponsored by Capital Medical University. Recruiting at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Endovascular treatment combined with a 240mg tocilizumab injection once
Drug: Tocilizumab
Endovascular treatment combined with placebo
Drug: Placebo
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.
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.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 days.
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
mRS score distribution
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days and 1 year
Early neurological improvement at 24 hours
Defined as a reduction in NIHSS score of at least 8 points from baseline or a score of 0 to 2
Time frame: 24 hours
NIHSS score at 7 days or at early discharge
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes
Time frame: 7 days
Proportion of patients with mRS score 0-1
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-2
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days and 1 year
Proportion of patients with mRS score 0-4
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days and 1 year
EQ-5D-5L
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.
Time frame: 90 days and 1 year
Proportion of Barthel Index (BI) 95-100
Time frame: 90 days and 1 year
Incidence of symptomatic intracranial hemorrhage within 24 hours
Time frame: 24 hours
Incidence of any intracranial hemorrhage within 24 hours
Time frame: 24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
Time frame: 7 days
Mortality
Time frame: 90 days and 1 year
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 1 year
Plan to share: Yes — Related data will be shared if full study protocol and statistical analysis plan are provided with reasonable design.
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Capital Medical University