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Not yet recruiting NCT07449910

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

Phase II / Phase III Interventional Acute Ichemic Stroke Anterior Cerebral Artery Stroke Baricitinib

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2mg Baricitinib, 4mg Baricitinib, Placebo, Guideline-based therapy.
Who it may be relevant to
Registry conditions: Acute Ichemic Stroke, Anterior Cerebral Artery Stroke, Baricitinib. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Distribution of 90-day mRS scores [Time frame: 90±14 days post-procedure]
Secondary outcome measures (7)
  • Proportion of patients with functional independence outcome (mRS 0-2) at 90-day [Time frame: 90±14 days post-procedure]
  • Proportion of patients with functional independence outcome (mRS 0-1) at 90-day [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 [Time frame: 90±14 days post-procedure]
  • Any symptomatic intracranial hemorrhage within 48h [Time frame: 48 hours post-procedure]
  • Any asymptomatic intracranial hemorrhage within 48h [Time frame: 48 hours post-procedure]
  • Any adverse event [Time frame: 90±14 days post-procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China, Hefei, Rec — Hefei

Identifiers

NCT: NCT07449910 · BEACON

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗