Actively Recruiting
Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child A or B Liver Cirrhosis
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2025-02-13
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of direct oral anticoagulant drugs (DOACs), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis. The study focuses on how these drugs influence thrombin generation, a process important in blood clotting, in this patient group. Researchers want to understand the pharmacokinetics and pharmacodynamics to help guide future larger studies on improving outcomes for liver cirrhosis patients using DOACs. Participants are randomly assigned to receive either apixaban (Eliquis ) or edoxaban (Lixiana ) at therapeutic doses for 7 consecutive days. Blood samples are collected before and after drug intake on days 1 and 3, as well as on days 8 and 9 to measure drug levels and thrombin generation parameters. This includes both in vivo and ex vivo assessments, aiming to evaluate how these medications affect clotting activity over time. During the trial, patients undergo multiple blood tests to monitor thrombin generation markers and drug concentrations at specified intervals. Safety is also assessed through monitoring adverse events until day 14. The study helps clarify the blood-thinning effects of these DOACs in liver cirrhosis patients and supports the design of future clinical trials. Total participation lasts about two weeks with close observation and laboratory evaluations.
CONDITIONS
Brief Title
DOAC in Patients with Child a or B Liver Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with liver cirrhosis Child A or B
- Provided written informed consent
You will not qualify if you...
- Pregnancy
- Oesophageal varices grade higher than 1 or with red signs
- Active ulcer disease of the gastrointestinal tract
- History of haemorrhagic stroke
- Severe uncontrolled hypertension
- Recent brain, spinal, or eye surgery
- Kidney function unsuitable for DOAC treatment
- Taking antiplatelet drugs
- Taking anticoagulant drugs (VKA, LMWH, DOAC)
- Any contraindications to DOAC use
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive a therapeutic dose of either apixaban or edoxaban for 7 consecutive days. Blood samples are collected before and after drug intake at specified days to assess pharmacokinetics and pharmacodynamics.
Visits on Day 1, Day 3, Day 8, and Day 9 for blood sample collection
Duration - 14 days
Participants are monitored for safety and adverse events for up to 14 days after starting treatment.
Ongoing safety monitoring with 1 to 2 visits depending on participant status
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
L
Lorenzo Alberio, Prof Dr. med
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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