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Clinical Trial NCT07449910 for Acute Ichemic Stroke, Anterior Cerebral Artery Stroke, Baricitinib is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial Phase 2, Phase 3 750 Randomized

Not yet recruiting
Clinical Trial NCT07449910 is designed to study Treatment for Acute Ichemic Stroke, Anterior Cerebral Artery Stroke, Baricitinib. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 17 March 2026 until the study accrues 750 participants. Led by The First Affiliated Hospital of University of Science and Technology of China, this study is expected to complete by 31 January 2028. The latest data from ClinicalTrials.gov was last updated on 4 March 2026.
Brief 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.
Official Title

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

Conditions
Acute Ichemic StrokeAnterior Cerebral Artery StrokeBaricitinib
Other Study IDs
  • BEACON
NCT ID Number
NCT07449910
Start Date (Actual)
2026-03-17
Last Update Posted
2026-03-04
Completion Date (Estimated)
2028-01-31
Enrollment (Estimated)
750
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental2mg Baricitinib group+Guideline-based therapy
One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.
2mg Baricitinib
One 2mg Baricitinib tablet and one 2mg placebo tablet 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.
ExperimentalBaricitinib 4mg group+Guideline-based therapy
Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.
4mg Baricitinib
Two 2mg Baricitinib 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.
Active ComparatorSham group+Guideline-based therapy
Two 2mg placebo tablets are given three times a day once daily for 5 to 7 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
90±14 days post-procedure
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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).
90±14 days post-procedure
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).
90±14 days post-procedure
Change in NIHSS score at 5-7 days post-procedure
5-7 days post-procedure
Any mortality at 90±14 days
Primary Safety Endpoints
90±14 days post-procedure
Any symptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
48 hours post-procedure
Any asymptomatic intracranial hemorrhage within 48h
Secondary Safety Endpoints
48 hours post-procedure
Any adverse event
Asymptomatic intracranial hemorrhage
90±14 days post-procedure
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
The First Affiliated Hospital of University of Science and Technology of China logoThe First Affiliated Hospital of University of Science and Technology of China
Study Responsible Party
Wei Hu, Principal Investigator, Professor, The First Affiliated Hospital of University of Science and Technology of China
Study Central Contact
Contact: Wei Hu, MD, PhD, +86 055162284313, [email protected]
1 Study Locations in 1 Countries

Anhui

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting, Hefei, Anhui, 230001, China
Wei Hu, MD, PhD, Contact, +86 115155510611, [email protected]