DOAC in Patients with Child a or B Liver Cirrhosis

Recruiting now · Phase 2

Conditions studied: Liver Cirrhosis

In brief

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

Key facts

Study ID: NCT05869591
Run by: Centre Hospitalier Universitaire Vaudois
People needed: 40
Starts: 2024-01-18
Expected to finish: 2026-06-01
Last updated by the study team: 2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years or older
Patient with previously diagnosed liver cirrhosis Child A or B
Written informed consent

You may not qualify if…

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

Where it is running

Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.