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

University of Science and Technology of China (USTC)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Acute Ichemic Stroke; Baricitinib; Anterior Cerebral Artery Stroke

Treatments: Drug: 4mg Baricitinib; Drug: 2mg Baricitinib; Other: Guideline-based therapy; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07449910

BEACON

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

750 participants in 3 patient groups

2mg Baricitinib group+Guideline-based therapy

Experimental group

Description:

One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.

Treatment:

Other: Guideline-based therapy

Drug: 2mg Baricitinib

Baricitinib 4mg group+Guideline-based therapy

Experimental group

Description:

Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.

Treatment:

Other: Guideline-based therapy

Drug: 4mg Baricitinib

Sham group+Guideline-based therapy

Active Comparator group

Description:

Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.

Treatment:

Drug: Placebo

Other: Guideline-based therapy