Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• Patient with previously diagnosed liver cirrhosis Child A or B
• Written informed consent
Locations
Other Locations
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Lorenzo Alberio, Prof Dr. med
lorenzo.alberio@chuv.ch
0041213140171
Time Frame
Start Date:2024-01-18
Estimated Completion Date:2026-06
Participants
Target number of participants:40
Treatments
Experimental: Cirrhotic patients with Child A or B under apixaban
Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of apixaban (Eliquis®) for 7 consecutive days.~Blood samples will be collected just before and after apixban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.~In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters \[ST Genesia (Drugscreen)\], as well as peak and trough apixaban levels will be measured.
Experimental: Cirrrhotic patients with Child A or B under edoxaban
Twenty non-anticoagulated patients with Child A or B liver cirrhosis will receive a therapeutic dose of edoxaban (Lixiana®) for 7 consecutive days.~Blood samples will be collected just before and after edoxaban intake at day 1 and 3. Another blood samples are collected at day 8 and at day 9.~In vivo thrombin generation parameters (F1+2, TAT, fibrin monomers, D-dimers), ex vivo thrombin generation parameters \[ST Genesia (Drugscreen)\], as well as peak and trough edoxaban levels will be measured.