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Not yet recruiting NCT07602062

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

No phase Interventional Portal Vein Thrombosis Anticoagulant Therapy Variceal Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rivaroxaban.
Who it may be relevant to
Registry conditions: Portal Vein Thrombosis, Anticoagulant Therapy, Variceal Bleeding. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Rivaroxaban
    Rivaroxaban 10mg qd po for 6 months

Primary outcome measures

  • Adverse events at 6 months [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (10)
  • Adverse events at 1months [Time frame: From enrollment to 1months of treatment]
  • Adverse events at 2 months [Time frame: From enrollment to the 2 months of treatment]
  • liver function at 6 months of treatment [Time frame: From the enrollment to 6 months of treatment]
  • renal function at 6 months of treatment [Time frame: From the enrollment to 6 months of treatment]
  • Hemodynamic changes at 6 months [Time frame: From enrollment to the end of treatment at 6 months]
  • Patency of portal vein thrombosis at 6 months [Time frame: From enrollment to the end of treatment at 6 months]
  • liver stiffness at 6 months [Time frame: From enrollment to the end of treatment at 6 months]
  • spleen stiffness at 6 months [Time frame: From enrollment to the end of treatment at 6 months]
  • Rivaroxaban Plasma Concentration at 6 Months [Time frame: From enrollment to the end of treatment at 6 months]
  • Serum metabolomics at 6 months [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Dr. Huang xiaoquan — Shanghai

Identifiers

NCT: NCT07602062 · KY2026028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗