Compensatory liver cirrhosis
Conditions
Interventions
Intervention group:rivaroxaban 10mg, orally once a day for 96 weeks
Control group:No any anti liver fibrosis medicine include TCM
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. F4 and cirrhosis were diagnosed by ultrasound or CT/MRI; 3. Hepatitis B cirrhosis: LSM twice (6 months apart) > 12 KPA; hepatitis C cirrhosis LSM > 14.3kPa; 4. At least 12 months before enrollment: HBVDNA in patients with hepatitis B cirrhosis was lower than the lower limit of detection value, and HCVRNA was negative in patients with hepatitis C cirrhosis; 5. Gastroscopy showed that degree I esophageal varices or treated esophageal varices were less than degree I, or degree II esophageal varices were treated with ß-receptor antagonists, carvedilol and other drugs; 6. HAS-BLED<=2; 7. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.No previous history of decompensation, such as upper gastrointestinal bleeding, ascites, hepatic encephalopathy, etc. 2.History of heavy drinking: >210g/L/week for men and >140g/L week for women. 3.Other causes of liver cirrhosis, such as non-alcoholic fatty liver associated cirrhosis. 4.Have a history of hemorrhagic diseases, such as cerebral hemorrhage, etc. 5.Uncontrolled hypertension (systolic blood pressure > 160mmHg) 6.PLT<50×109/L 7.Portal vein thrombosis 8.Other anticoagulant or antiplatelet drugs are being used, such as aspirin, low molecular weight heparin, warfarin, etc. 9.Liver cancer or other serious diseases and tumors of the system, such as circulatory system, respiratory system, urinary system dysfunction or failure, etc. 10.Hematological diseases, such as thrombosis, tumor, etc. 11.Splenectomy within 6 months. 12.Abdominal surgery or inflammation within 6 months. 13.Be allergic to this drug. 14.Pregnancy or lactation. 15.Use cytochrome P4503A4 inhibitors (ketoconazole, protease inhibitor antiretroviral therapy for human immunodeficiency virus patients) or cytochrome inducers (rifampicin), phenytoin sodium, etc. 16.Patients who are using drugs for promoting blood circulation and removing blood stasis and anti-fibrosis and liver cirrhosis. 17.Participate in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 96 weeks, the improvement of MRE liver elasticity was compared between the intervention group and the control group.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fibroscan;Other non-invasive indicators of hepatic fibrosis: APRI,FIB-4;Improvement of liver function: Child-Pugh score, MELD score, ICG15 minute retention rate;Incidence of decompensation;Safety indicators: incidence of hemorrhage; incidence of massive hemorrhage; incidence of drug-induced liver injury;The relationship between the level of anti-FXa antibody and bleeding and curative effect; | — |
Countries
China
Contacts
Public ContactZhang Jing
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed