NCT05869591 DOAC in Patients with Child a or B Liver Cirrhosis
| NCT ID | NCT05869591 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-01-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Lorenzo Alberio, Prof Dr. med
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT05869591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05869591 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05869591 currently recruiting?
Yes, NCT05869591 is actively recruiting participants. Contact the research team at lorenzo.alberio@chuv.ch for enrollment information.
Where is the NCT05869591 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05869591 clinical trial?
NCT05869591 is sponsored by Centre Hospitalier Universitaire Vaudois. The principal investigator is Lorenzo Alberio, Prof Dr. med at CHUV. The trial plans to enroll 40 participants.