Investigating direct oral anticoagulants in patients with liver cirrhosis
Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis
This study is testing if the blood-thinning medications apixaban and edoxaban can help people with liver cirrhosis by reducing blood clotting over a week of treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT05869591 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the pharmacokinetics and pharmacodynamics of direct oral anticoagulants (DOACs), specifically apixaban and edoxaban, in patients with Child A or B liver cirrhosis. Participants will be randomly assigned to receive either apixaban or edoxaban at a therapeutic dosage for seven consecutive days. The primary goal is to assess the ability of these medications to reduce thrombin generation in patients with liver cirrhosis, which may help improve their clinical outcomes. The findings will inform the design of a larger multicenter study to evaluate the efficacy of DOACs in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a diagnosis of Child A or B liver cirrhosis.
Not a fit: Patients with severe uncontrolled hypertension, active gastrointestinal ulcer disease, or those with contraindications for DOAC administration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with liver cirrhosis, potentially reducing complications associated with venous thromboembolism.
How similar studies have performed: While some studies have shown the effectiveness of DOACs in similar populations, this specific investigation is novel in its focus on liver cirrhosis patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lausanne, Canton of Vaud
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lorenzo Alberio, Prof Dr. med — Chuv
- Study coordinator: Lorenzo Alberio, Prof Dr. med
- Email: lorenzo.alberio@chuv.ch
- Phone: 0041213140171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.