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RECRUITING
NCT05869591
PHASE2

DOAC in Patients with Child a or B Liver Cirrhosis

Sponsor: Centre Hospitalier Universitaire Vaudois

View on ClinicalTrials.gov

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

Official title: Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-01-18

Completion Date

2026-06

Last Updated

2025-02-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Apixaban 5 MG [Eliquis]

Pharmacokinetics and pharmacodynamics assessment of apixaban in patients with Child A or B liver cirrhosis

DRUG

Edoxaban 60 MG [Lixiana]

Pharmacokinetics and pharmacodynamics assessment of edoxaban in patients with Child A or B liver cirrhosis

Locations (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland