Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05869591

DOAC in Patients with Child a or B Liver Cirrhosis

Led by Centre Hospitalier Universitaire Vaudois · Updated on 2025-02-13

40

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

DOAC in Patients with Child a or B Liver Cirrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient with previously diagnosed liver cirrhosis Child A or B
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Oesophageal varices with grade superior to 1 or with red signs
  • Active ulcer disease of the gastrointestinal tract
  • History of haemorrhagic stroke
  • Severe uncontrolled hypertension
  • Recent brain, spinal or ophthalmic surgery
  • Kidney function inadequate for DOAC treatment
  • Concomitant treatment with anti-platelet drugs
  • Concomitant treatment with anticoagulant drugs (VKA, LMWH, DOAC)
  • Any contraindications for DOAC administration
  • Inability to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

L

Lorenzo Alberio, Prof Dr. med

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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