DOAC in Patients with Child a or B Liver Cirrhosis
NCT05869591
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
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
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NCT05869591