Impact of Apixaban on hepatic decompensation in cirrhosis: A parallel-group open-label randomized controlled trial - ApiHep

AIIMS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

暂无简介。

•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
•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

发起方