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NCT Number: NCT07602062

Direct Oral Novel Anticoagulants for 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Huang xiaoquan

Shanghai, China

Location contact

xiaoquan Huang Dr.

CONTACT

[email protected]

+86+‭18801733835

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban 10mg qd po for 6 months

Primary outcomes

  1. Adverse events at 6 months

    Time frame: From enrollment to the end of treatment 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.

Secondary outcomes

  1. Adverse events at 1months

    Time frame: From enrollment to 1months of treatment

    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

  2. Adverse events at 2 months

    Time frame: From enrollment to the 2 months of treatment

    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

  3. liver function at 6 months of treatment

    Time frame: From the enrollment to 6 months of treatment

    Changes in liver function at 6 months of treatment measured by ALT/AST/Total Bilirubin level

  4. renal function at 6 months of treatment

    Time frame: From the enrollment to 6 months of treatment

    Changes in renal function at 6 months of treatment measured by serum creatinine level

  5. Hemodynamic changes at 6 months

    Time frame: From enrollment to the end of treatment at 6 months

    flow velocity of the portal vein system (m/s) measured by ultrasound

  6. Patency of portal vein thrombosis at 6 months

    Time frame: From enrollment to the end of treatment at 6 months

    changes of portal vein thrombosis measured by CT Venography at 6 months (progress or recanalization)

  7. liver stiffness at 6 months

    Time frame: From enrollment to the end of treatment at 6 months

    liver stiffness after 6 months of treatment measured by fibroscan

  8. spleen stiffness at 6 months

    Time frame: From enrollment to the end of treatment at 6 months

    spleen stiffness after 6 months of treatment measured by fibroscan.

  9. Rivaroxaban Plasma Concentration at 6 Months

    Time frame: From enrollment to the end of treatment at 6 months

    Changes in Rivaroxaban Plasma Concentration After 6 Months of Treatment

  10. Serum metabolomics at 6 months

    Time frame: From enrollment to the end of treatment at 6 months

    metabolomic analysis of the patients' serum after treatment for 6 months using Liquid Chromatography-Mass Spectrometry (LC-MS)

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyao Chen Prof.

CONTACT

[email protected]

+86+‭136 0176 7310‬

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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