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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Distribution of 90-day mRS scores [Срок оценки: 90±14 days post-procedure]

Вторичные конечные точки (7)

• Proportion of patients with functional independence outcome (mRS 0-2) at 90-day [Срок оценки: 90±14 days post-procedure]
• Proportion of patients with functional independence outcome (mRS 0-1) at 90-day [Срок оценки: 90±14 days post-procedure]
• Change in NIHSS score at 5-7 days post-procedure [Срок оценки: 5-7 days post-procedure]
• Any mortality at 90±14 days [Срок оценки: 90±14 days post-procedure]
• Any symptomatic intracranial hemorrhage within 48h [Срок оценки: 48 hours post-procedure]
• Any asymptomatic intracranial hemorrhage within 48h [Срок оценки: 48 hours post-procedure]
• Any adverse event [Срок оценки: 90±14 days post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of University of Science and Technology of China, Hefei, Rec — Хэфэй

Идентификаторы

NCT: NCT07449910 · BEACON

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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