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

NCT07449910 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of University of Science and Technology of China

Phase

Phase 2/3

Started

2026-03-17

Last updated

2026-03-04

Condition(s) studied

Acute Ichemic StrokeAnterior Cerebral Artery StrokeBaricitinib

Investigational drug(s) / intervention(s)

2mg Baricitinib →4mg Baricitinib →PlaceboGuideline-based therapy

2mg Baricitinib: One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.

4mg Baricitinib: Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.

Placebo: Two 2mg placebo tablets are given three times a day, last for 5±2 days.

Guideline-based therapy: Guideline-based therapy including EVT treatment is determined by the physician.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age is 18 years old or above. 2. Diagnosed as anterior circulation large vessel occlusion stroke by CTA, MRA or DSA. 3. Randomized within 24h after the onset. 4. The NIHSS score is above 5 and the ASPECT score is above 3 points while receiving imaging examination; 5. The mTICI score after endovascular treatment (EVT) is above 2b. 6. informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT or MRI. 2. mRS score\>2 for patients \<80 years, or mRS score\>1 for those ≥80 years before onset. 3. Pregnant or lactating women. 4. Allergic to contrast agents. 5. Allergic to baricitinib or having contraindications for using baricitinib. 6. Participating in other clinical studies. 7. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, and unable to be controlled by oral antihypertensive drugs. 8. Genetic or acquired bleeding diathesis, lack of anticoagulant factors or having taken oral anticoagulants and INR \>1.7. 9. Hemoglobin value \<8g/L. 10. Recent history of using other JAK inhibitors or potent immunosuppressants, including but not limited to the combined use with potent immunosuppressive drugs such as azathioprine, tacrolimus, tofacitinib and fedratinib, etc. Tortuous arteries make the thrombectomy device unable to reach the target blood vessel. 11. Previous history of diagnosed viral hepatitis and tuberculosis.

Primary outcome measure(s)

Distribution of 90-day mRS scores — 90±14 days post-procedure
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.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting	Hefei	Anhui

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07449910 on ClinicalTrials.gov ↗ ← All trials in China