A study to determine role of Apixaban in reducing complications in liver cirrhosis
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2023/09/058018
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <12 months
10. Renal impairment (creatinine clearance <30 ml/min or on hemodialysis)
11. HE grades 2 or higher
12. Severe thrombocytopenia <20k/mm3
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. John’s wort)
17. Coadministration of antiplatelet drugs
18. Participation in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method