drugset / Trial / NCT05869591

DOAC in Patients with Child a or B Liver Cirrhosis

NCT05869591

Phase 2 Recruiting 40 enrolled Centre Hospitalier Universitaire Vaudois
RandomizedParallel-groupOpen-labelOther

Summary

The goal of this clinical trial is to investigate pharmacokinetics and pharmacodynamics of direct oral anticoagulant drugs (DOAC), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis (LC). The primary objective of this study is to verify the ability of apixaban and edoxaban to decrease in vivo thrombin generation in LC patients. Participants will be randomly assigned to either apixaban (Eliquis®) or edoxaban (Lixiana®) at a therapeutic dosage for 7 consecutive days. The results of this investigation will contribute to designing a prospective multicentre interventional study to investigate the efficacy of DOAC to improve clinical outcomes in patients with LC

Timeline

Start
2024-01-18
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 5 mg Oral
Subject Edoxaban Small molecule 60 mg Oral

Indications