Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

Официальное название

Multicenter Randomized Controlled Clinical Trial on Direct Oral Novel Anticoagulants for Improving the Prognosis of Cirrhotic Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

Обзор

This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.

Вмешательства

• Препарат Rivaroxaban
  Rivaroxaban 10mg qd po for 6 months

Первичные конечные точки

• Adverse events at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (10)

• Adverse events at 1months [Срок оценки: From enrollment to 1months of treatment]
• Adverse events at 2 months [Срок оценки: From enrollment to the 2 months of treatment]
• liver function at 6 months of treatment [Срок оценки: From the enrollment to 6 months of treatment]
• renal function at 6 months of treatment [Срок оценки: From the enrollment to 6 months of treatment]
• Hemodynamic changes at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Patency of portal vein thrombosis at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• liver stiffness at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• spleen stiffness at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Rivaroxaban Plasma Concentration at 6 Months [Срок оценки: From enrollment to the end of treatment at 6 months]
• Serum metabolomics at 6 months [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding
• Combined with portal vein thrombosis and D-dimer > 0.8mg/L
• Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices
• Signed informed consent form

Критерии исключения

• Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)
• Combined with hepatocellular carcinoma or other malignancy
• Combined with portal cavernoma
• Combined with severe life-threatening diseases of circulatory, hematological and respiratory system
• Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism
• Received TIPS or liver transplantation or splenectomy
• With contraindications to anticoagulant therapy (uncontrollable active bleeding, severe hepatic insufficiency, renal insufficiency, etc.)
• Currently taking immunosuppressive agents, or medications that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong inducers of CYP3A4 (including rifampicin, phenytoin, carbamazepine, etc.)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Dr. Huang xiaoquan — Шанхай

Идентификаторы

NCT: NCT07602062 · KY2026028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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