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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
Rivaroxaban 10mg qd po for 6 months
Dr. Huang xiaoquan
Shanghai, China
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
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
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
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
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
Hemodynamic changes at 6 months
flow velocity of the portal vein system (m/s) measured by ultrasound
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: From enrollment to the end of treatment at 6 months