Safety and Efficacy of Baricitinib Combined With Acute Large Vessel Occlusion Recanalization : A Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Distribution of 90-day mRS scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
2mg Baricitinib group+Guideline-based therapy
One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.
干预措施: 2mg Baricitinib (Drug)
2mg Baricitinib group+Guideline-based therapy
One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days.
干预措施: Guideline-based therapy (Other)
Baricitinib 4mg group+Guideline-based therapy
Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.
干预措施: 4mg Baricitinib (Drug)
Baricitinib 4mg group+Guideline-based therapy
Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days.
干预措施: Guideline-based therapy (Other)
Sham group+Guideline-based therapy
Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.
干预措施: Placebo (Drug)
Sham group+Guideline-based therapy
Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days.
干预措施: Guideline-based therapy (Other)
结局指标
主要结局
Distribution of 90-day mRS scores
时间窗: 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.
次要结局
- Any mortality at 90±14 days(90±14 days post-procedure)
- Proportion of patients with functional independence outcome (mRS 0-2) at 90-day(90±14 days post-procedure)
- Proportion of patients with functional independence outcome (mRS 0-1) at 90-day(90±14 days post-procedure)
- Change in NIHSS score at 5-7 days post-procedure(5-7 days post-procedure)
- Any symptomatic intracranial hemorrhage within 48h(48 hours post-procedure)
- Any asymptomatic intracranial hemorrhage within 48h(48 hours post-procedure)
- Any adverse event(90±14 days post-procedure)
研究者
Wei Hu
Professor
The First Affiliated Hospital of University of Science and Technology of China