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.

Study Overview

• Status: Not yet recruiting
• Conditions: Portal Vein Thrombosis; Variceal Bleeding; Anticoagulant Therapy
• Intervention / Treatment: Drug: Rivaroxaban

• Study Type: Interventional
• Enrollment (Estimated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyao Chen Prof.; Phone Number: +86+‭136 0176 7310‬; Email: chen.shiyao@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Dr. Huang xiaoquan
    • Contact: xiaoquan Huang Dr.; Phone Number: +86+‭18801733835; Email: huang.xiaoquan@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: anticoagulant group; Rivaroxaban 10mg qd po. for 6 months	Drug: Rivaroxaban; Rivaroxaban 10mg qd po for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events at 6 months	Within 6 months, the time from randomization to the first occurrence of any of the following events: including gastrointestinal bleeding, new onset or worsening of ascites > grade II, new onset or worsening of portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, and occurrence of death.	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events at 1months	Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death	From enrollment to 1months of treatment
Adverse events at 2 months	Gastrointestinal bleeding, new or aggravated ascites > Grade II, new or aggravated portal vein thrombosis, treatment with interventional transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation, death	From enrollment to the 2 months of treatment
liver function at 6 months of treatment	Changes in liver function at 6 months of treatment measured by ALT/AST/Total Bilirubin level	From the enrollment to 6 months of treatment
renal function at 6 months of treatment	Changes in renal function at 6 months of treatment measured by serum creatinine level	From the enrollment to 6 months of treatment
Hemodynamic changes at 6 months	flow velocity of the portal vein system (m/s) measured by ultrasound	From enrollment to the end of treatment at 6 months
Patency of portal vein thrombosis at 6 months	changes of portal vein thrombosis measured by CT Venography at 6 months (progress or recanalization）	From enrollment to the end of treatment at 6 months
liver stiffness at 6 months	liver stiffness after 6 months of treatment measured by fibroscan	From enrollment to the end of treatment at 6 months
spleen stiffness at 6 months	spleen stiffness after 6 months of treatment measured by fibroscan.	From enrollment to the end of treatment at 6 months
Rivaroxaban Plasma Concentration at 6 Months	Changes in Rivaroxaban Plasma Concentration After 6 Months of Treatment	From enrollment to the end of treatment at 6 months
Serum metabolomics at 6 months	metabolomic analysis of the patients' serum after treatment for 6 months using Liquid Chromatography-Mass Spectrometry (LC-MS)	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Thiophenes; Rivaroxaban
• Other Study ID Numbers: KY2026028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Privacy policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No