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RecruitingPhase 2NCT05869591

DOAC in Patients with Child a or B Liver Cirrhosis

Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis

Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

40 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhosis

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria11

  • 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

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Interventions

DRUGApixaban 5 MG [Eliquis]

Pharmacokinetics and pharmacodynamics assessment of apixaban in patients with Child A or B liver cirrhosis

DRUGEdoxaban 60 MG [Lixiana]

Pharmacokinetics and pharmacodynamics assessment of edoxaban in patients with Child A or B liver cirrhosis

Locations(1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

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NCT05869591

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