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

NCT07602062 | Not Yet Recruiting

• 1 other identifier: KY2026028
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Portal Vein Thrombosis; Anticoagulant Therapy; Variceal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Adverse events at 1months

  From enrollment to 1months of treatment

• Adverse events at 2 months

  From enrollment to the 2 months of treatment

• liver function at 6 months of treatment

  From the enrollment to 6 months of treatment

• renal function at 6 months of treatment

  From the enrollment to 6 months of treatment

• Hemodynamic changes at 6 months

  From enrollment to the end of treatment at 6 months

Study Arms (2)

anticoagulant group

EXPERIMENTAL

Rivaroxaban 10mg qd po. for 6 months

Drug: Rivaroxaban

control group

NO INTERVENTION

Interventions

Rivaroxaban DRUG

Rivaroxaban 10mg qd po for 6 months

anticoagulant group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Dr. Huang xiaoquan

Shanghai, China

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Shiyao Chen Prof.

CONTACT

+86+‭136 0176 7310‬; chen.shiyao@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)