Anticoagulant Therapy, Portal Vein Thrombosis, Variceal Bleeding
Conditions
Brief summary
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
DRUGRivaroxaban
Rivaroxaban 10mg qd po for 6 months
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events at 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events at 1months | 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 |
| Adverse events at 2 months | 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 |
| liver function at 6 months of treatment | From the enrollment to 6 months of treatment | Changes in liver function at 6 months of treatment measured by ALT/AST/Total Bilirubin level |
| renal function at 6 months of treatment | From the enrollment to 6 months of treatment | Changes in renal function at 6 months of treatment measured by serum creatinine level |
| Hemodynamic changes at 6 months | From enrollment to the end of treatment at 6 months | flow velocity of the portal vein system (m/s) measured by ultrasound |
| Patency of portal vein thrombosis at 6 months | 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） |
| liver stiffness at 6 months | From enrollment to the end of treatment at 6 months | liver stiffness after 6 months of treatment measured by fibroscan |
| spleen stiffness at 6 months | From enrollment to the end of treatment at 6 months | spleen stiffness after 6 months of treatment measured by fibroscan. |
| Rivaroxaban Plasma Concentration at 6 Months | From enrollment to the end of treatment at 6 months | Changes in Rivaroxaban Plasma Concentration After 6 Months of Treatment |
| Serum metabolomics at 6 months | 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) |
Countries
China
Contacts
CONTACTShiyao Chen Prof.
Outcome results
None listed