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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)