Investigating direct oral anticoagulants in patients with liver cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to explore the pharmacokinetics and pharmacodynamics of direct oral anticoagulants (DOACs), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis. Participants will be randomly assigned to receive either apixaban or edoxaban at a therapeutic dosage for seven consecutive days. The primary goal is to assess the ability of these medications to reduce thrombin generation in patients with liver cirrhosis, which may help improve their clinical outcomes. The findings will inform the design of a larger multicenter study to evaluate the efficacy of DOACs in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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's running

• Centre Hospitalier Universitaire Vaudois (CHUV)
  Lausanne, Canton of Vaud, Switzerland Recruiting

Study contacts

• Principal investigator: Lorenzo Alberio, Prof Dr. med — Chuv
• Study coordinator: Lorenzo Alberio, Prof Dr. med
• Email: lorenzo.alberio@chuv.ch
• Phone: 0041213140171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.