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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anticoagulant group | Experimental | Rivaroxaban 10mg qd po. for 6 months |
|
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 10mg qd po for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to 1months of treatment |
| Adverse events at 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyao Chen Prof. | Contact | +86+â€136 0176 7310‬ | chen.shiyao@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Huang xiaoquan | Shanghai | China |
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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 |
| 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 | 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 | 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 | 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) | 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 | 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. | 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 | 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) | From enrollment to the end of treatment at 6 months |
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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