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

Starting soon · Not applicable

Conditions studied: Portal Vein Thrombosis, Anticoagulant Therapy, Variceal Bleeding

In brief

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.

Key facts

Study ID

NCT07602062

Run by

Shanghai Zhongshan Hospital

People needed

175

Starts

2026-06-01

Expected to finish

2027-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Dr. Huang xiaoquan — Shanghai, China

Full record on ClinicalTrials.gov

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