DOAC in Patients With Child B Liver Cirrhosis

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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 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 for primary prevention of portal vein thrombosis in LC patients at high thrombotic risk.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Treatments: Apixaban; Edoxaban

Criteria

Inclusion Criteria:

• Age 18 years or older

• Patient already assessed in the previous study (CER-VD 2018-02157) and demonstrating a procoagulant profile

• Patient with previously diagnosed liver cirrhosis Child B

• Written informed consent

Exclusion Criteria:

• Pregnancy

• Oesophageal varices

• 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