|

DOAC in Patients with Child a or B Liver Cirrhosis

RECRUITINGPhase 2Sponsored by Centre Hospitalier Universitaire Vaudois
Actively Recruiting
PhasePhase 2
SponsorCentre Hospitalier Universitaire Vaudois
Started2024-01-18
Est. completion2026-06
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Liver CirrhosisLiver Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.