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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
348
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.
Nanyang Central Hospital
Nanyang, Henan, China
RECRUITINGPeople's Hospital of Xihua
Zhoukou, Henan, China
RECRUITINGPeople's Hospital of Linyi
Linyi, Shandong, China
RECRUITINGTaizhou enze Hospital
Taizhou, Zhejiang, China
RECRUITINGPeople's Hospital of Yueqing
Yueqing, Zhejiang, China
RECRUITINGCapital Medical Univercity Xuanwu Hospital
Beijing, China
RECRUITINGProportion 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 at 90 days;
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
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 at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
Proportion of patients with mRS score 0-2 at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
Proportion of patients with mRS score 0-4 at 90 days
The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.
Time frame: 90 days
EQ-5D-5L at 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.
Time frame: 90 days
Proportion of Barthel Index (BI) 95-100 at 90 days
Time frame: 90 days
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