The primary purpose of this study is to evaluate the efficacy and safety of Baricitinib combined with endovascular therapy in patients with acute anterior circulation large vessel occlusion, to address futile recanalization with priority, and to elucidating the mechanism of JAK/STAT pathway inhibition on neuroprotection and inflammatory regulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
750
One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.
Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
Two 2mg placebo tablets are given three times a day, last for 5±2 days.
Guideline-based therapy including EVT treatment is determined by the physician.
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting
Hefei, Anhui, China
Distribution of 90-day mRS scores
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
Time frame: 90±14 days post-procedure
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).
Time frame: 90±14 days post-procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death).
Time frame: 90±14 days post-procedure
Change in NIHSS score at 5-7 days post-procedure
Time frame: 5-7 days post-procedure
Any mortality at 90±14 days
Primary Safety Endpoints
Time frame: 90±14 days post-procedure
Any symptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
Time frame: 48 hours post-procedure
Any asymptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
Time frame: 48 hours post-procedure
Any adverse event
Asymptomatic intracranial hemorrhage
Time frame: 90±14 days post-procedure
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