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

ConditionsPortal Vein ThrombosisAnticoagulant TherapyVariceal Bleeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Rivaroxaban

    Drug

    Rivaroxaban 10mg qd po for 6 months

Treatment groups

175 Participants
are divided into 2 treatment groups
Group A: anticoagulant groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

Time frame
From enrollment to 1months of treatment
2

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

Time frame
From enrollment to the 2 months of treatment
3

liver function at 6 months of treatment

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

Time frame
From the enrollment to 6 months of treatment
4

renal function at 6 months of treatment

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

Time frame
From the enrollment to 6 months of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: