Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Apixaban plus standard of care: Tablet Apixaban 5 mg twice daily orally plus standard of care (routine medications according to existing guidelines) for 1 year.
Control Intervention1: S
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: A. Adults more than or equal to 18 years B. Patients diagnosed with cirrhosis based on clinical and/or laboratory criteria, ultrasound/fibroscan/liver biopsy. C. Thrombosis in portal venous system D. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Hepatic venous outflow tract obstruction 2. Triple positive antiphospholipid antibody syndrome 3. Hepatocellular or malignant neoplasia at the time of inclusion 4. Active bleeding from any site (e.g., active variceal bleeding) 5. High risk varices at the time of inclusion 6. Hypersensitivity to active ingredients or excipients 7. Pregnancy and lactation 8. Any comorbidity involving therapeutic limitation and/or life expectancy less than 12 months 9. Renal impairment (creatinine clearance less than 15 ml/min or on hemodialysis) 10. HE grades 2 or higher 11. Severe thrombocytopenia less than 20k/mm3 12. TIPSS 13. Potent dual inhibitors of CYP3A4 and P-gp, (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin) or dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) 14. Coadministration of antiplatelet drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with partial or complete recanalization of portal venous thrombosisTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events-major and minor bleedTimepoint: 12 months;Proportion of patients with progression of portal venous thrombosisTimepoint: 12 months;Predictors of recanalization of thrombosis Timepoint: 12 months;Frequency of individual and composite of liver-related events (ascites, hepatic encephalopathy, variceal bleeding, ACLF and HCC)Timepoint: 12 months;Change in CTP, MELD and non-invasive liver fibrosis scoreTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Shalimar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed