Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial

Sponsor
The First Affiliated Hospital of University of Science and Technology of China
Study ID
NCT07449910
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Ichemic Stroke
  • Anterior Cerebral Artery Stroke
  • Baricitinib

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 2mg Baricitinib — DRUG
    One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.
  • 4mg Baricitinib — DRUG
    Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
  • Placebo — DRUG
    Two 2mg placebo tablets are given three times a day, last for 5±2 days.
  • Guideline-based therapy — OTHER
    Guideline-based therapy including EVT treatment is determined by the physician.

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Feb 2026
Primary completion
Aug 17, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2mg Baricitinib group+Guideline-based therapy
    One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.
  • Experimental: Baricitinib 4mg group+Guideline-based therapy
    Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.
  • Active Comparator: Sham group+Guideline-based therapy
    Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.

Primary Outcome Measure

Distribution of 90-day mRS scores [ Time Frame: 90±14 days post-procedure ]

Central Contacts

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