Investigating Rivaroxaban and Apixaban in Patients with Liver Cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the pharmacokinetic and pharmacodynamic effects of rivaroxaban and apixaban in patients with compensated liver cirrhosis, specifically those classified as Child-Pugh class A and B. Participants will receive a single oral dose of either medication, followed by blood sample collection at various intervals to assess drug absorption and effects. A follow-up call will be conducted five days post-dose to gather safety information. The study seeks to improve anticoagulation strategies for patients with liver cirrhosis, addressing limitations of current treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older
* Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
* Written informed consent

Exclusion Criteria:

* Positive pregnancy test (only for women in childbearing age with intact uterus), pregnancy or nursing women
* Intake of prophylactic or therapeutic oral anticoagulant (phenprocoumon, acenocoumarol, dabigatran etc.) 2 weeks prior to inclusion in the study
* Application of parenteral anticoagulant, e.g. unfractionated heparin, low molecular weight heparins, heparin derivatives (fondaparinux etc.) 1 week prior to inclusion in the study
* Pharmacologic platelet inhibition within 2 weeks prior to inclusion in the study
* Known coagulation disorders (e.g. von Willebrand's disease, hemophilia)
* Active, clinically significant bleeding
* Congenital or acquired bleeding disorder
* High risk of bleeding (e.g. active ulcerative gastrointestinal disease)
* Uncontrolled severe hypertension
* Vascular retinopathy
* Acute infection
* Acute bacterial endocarditis
* Severe anemia (haemoglobin ≤100 g/L)
* Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Severe liver dysfunction (Child-Pugh Score grade C)
* Hepatic encephalopathy ≥ grade 3
* Severe renal impairment with a creatinine clearance (GFR) of \<30 ml/min
* Known intolerance to the study medications rivaroxaban and/or apixaban
* Concomitant treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, lopinavir, ritonavir, indinavir).
* Concomitant treatment with a P-glycoprotein inhibitor and a weak or moderate CYP3A4 inhibitor (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine).
* Concomitant treatment with a P-glycoprotein inducer and a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampicin).
* Wash-out period of less than two weeks prior to the application of study drug in case of prior treatment with a strong CYP3A4 inhibitor or a P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor or with a P-glycoprotein inducer or strong CYP3A4 inducer.

Where it's running

• Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Dr. med. Guido Stirnimann — Insel Gruppe AG, University Hospital Bern
• Study coordinator: Dr. med. Guido Stirnimann
• Email: guido.stirnimann@insel.ch
• Phone: +41 31 632 47 13

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.