About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age is 18 years old or above.
Diagnosed as anterior circulation large vessel occlusion stroke by CTA, MRA or DSA.
Randomized within 24h after the onset.
The NIHSS score is above 5 and the ASPECT score is above 3 points while receiving imaging examination;
Disqualifiers
Intracranial hemorrhage confirmed by CT or MRI.
mRS score>2 for patients <80 years, or mRS score>1 for those ≥80 years before onset.
Pregnant or lactating women.
Allergic to contrast agents.
Trial design
Parallel
Treatments tested in this trial
2mg Baricitinib
DrugOne 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.
4mg Baricitinib
DrugTwo 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
Placebo
DrugTwo 2mg placebo tablets are given three times a day, last for 5±2 days.
Guideline-based therapy
Other interventionGuideline-based therapy including EVT treatment is determined by the physician.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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).
Change in NIHSS score at 5-7 days post-procedure
Any mortality at 90±14 days
Primary Safety Endpoints
Sponsors and contacts
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