MedTrace Logo

DOAC in Patients with Child a or B Liver Cirrhosis

NCT05869591 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Lorenzo Alberio, Prof Dr. med · CHUV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869591 on ClinicalTrials.gov