Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Tablet Apixaban 2.5 mg twice daily orally plus standard of care for 1 year: Apixaban is an oral anticoagulant. It will be given twice daily orally for 1 year alongwith standard of care.
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years 2. Patients diagnosed with cirrhosis based on clinical and/or laboratory criteria, ultrasound/fibroscan/liver biopsy. 3. Child Pugh score 7-10 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Any previous or current thrombosis in the splenoportal axis (USG SpA axis doppler or CT/MR angiography) 2. Indication for the use of anticoagulant for other reasons 3. Any known thrombophilia 4. Active bleeding from any site (eg, active variceal bleeding) 5. High risk varices at the time of inclusion 6. Hypersensitivity to active ingredients or excipients 7. Pregnancy and lactation 8. HCC or malignant neoplasia at the time of inclusion 9. Any comorbidity involving therapeutic limitation and/or life expectancy 10. Renal impairment (creatinine clearance 11. HE grades 2 or higher 12. Severe thrombocytopenia 13. TIPS 14. CTP score >10 15. Active alcoholism with less than 3 months of abstinence. 16. 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. Johnâ??s wort) 17. Coadministration of antiplatelet drugs 18. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with new-onset or further hepatic decompensation (as defined by Baveno VII)Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of overall & liver-related mortalityTimepoint: 1 year;Incidence of adverse events- major & minor bleedTimepoint: 1 year;Change in HVPG at 1-year between the 2 groupsTimepoint: 1 year;Change in levels of Intestinal fatty acid binding protein, 16 S ribosomal DNA, CD14, IL6, lipopolysaccharide binding protein & lipopolysaccharideTimepoint: 1 year;Frequency of individual/composite liver-related events (including decompensations [defined by Baveno VII] alongwith acute-on-chronic liver failure [ACLF, according to EASL criteria] & hepatocellular carcinoma)Timepoint: 1 year;Change in CTP, MELD & non-invasive liver fibrosis scoresTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Ayush Agarwal
All India Institute of Medical Sciences
Outcome results
None listed