Dr. Huang xiaoquan
Shanghai, China
NCT Number: NCT07602062
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rivaroxaban 10mg qd po for 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.
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
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
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
Time frame: From the enrollment to 6 months of treatment
Changes in renal function at 6 months of treatment measured by serum creatinine level
Time frame: From enrollment to the end of treatment at 6 months
flow velocity of the portal vein system (m/s) measured by ultrasound
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)
Time frame: From enrollment to the end of treatment 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 after 6 months of treatment measured by fibroscan.
Time frame: From enrollment to the end of treatment 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
metabolomic analysis of the patients' serum after treatment for 6 months using Liquid Chromatography-Mass Spectrometry (LC-MS)
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
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
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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