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NCT Number: NCT07449910

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting

Hefei, Anhui, 230001, China

Location contact

Wei Hu, MD, PhD

CONTACT

[email protected]

+86 115155510611

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • The mTICI score after endovascular treatment (EVT) is above 2b.
  • informed consent.

Exclusion criteria

  • 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.
  • Allergic to baricitinib or having contraindications for using baricitinib.
  • Participating in other clinical studies.
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, and unable to be controlled by oral antihypertensive drugs.
  • Genetic or acquired bleeding diathesis, lack of anticoagulant factors or having taken oral anticoagulants and INR >1.7.
  • Hemoglobin value <8g/L.
  • 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.
  • Previous history of diagnosed viral hepatitis and tuberculosis.

Treatment and study plan

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.

Primary outcomes

  1. Distribution of 90-day mRS scores

    Time frame: 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.

Secondary outcomes

  1. Proportion of patients with functional independence outcome (mRS 0-2) at 90-day

    Time frame: 90±14 days post-procedure

    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).

  2. Proportion of patients with functional independence outcome (mRS 0-1) at 90-day

    Time frame: 90±14 days post-procedure

    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).

  3. Change in NIHSS score at 5-7 days post-procedure

    Time frame: 5-7 days post-procedure

  4. Any mortality at 90±14 days

    Time frame: 90±14 days post-procedure

    Primary Safety Endpoints

  5. Any symptomatic intracranial hemorrhage within 48h

    Time frame: 48 hours post-procedure

    Secondary Safety Endpoints

  6. Any asymptomatic intracranial hemorrhage within 48h

    Time frame: 48 hours post-procedure

    Secondary Safety Endpoints

  7. Any adverse event

    Time frame: 90±14 days post-procedure

    Asymptomatic intracranial hemorrhage

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Hu, MD, PhD

CONTACT

[email protected]

+86 055162284313

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Safety and Efficacy of Baricitinib Combined With Acute Large Vessel Occlusion Recanalization : A Multicenter, Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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