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.
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;
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;
Parallel
Tocilizumab
Drug240 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
DrugAn 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.
mRS score distribution
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
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
NIHSS score at 7 days or at early discharge
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes
Proportion of patients with mRS score 0-1
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Incidence of symptomatic intracranial hemorrhage within 24 hours
Incidence of any intracranial hemorrhage within 24 hours
Proportion of patients with pneumonia at 7 days or at early discharge
Mortality
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