The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban and apixaban in patients with compensated liver cirrhosis (Child-Pugh class A and B).
The enrolled participants receive a prophylactic single oral dose of either rivaroxaban (10 mg) or apixaban (2.5 mg) at around 8 a.m. on the day of the trial. Blood samples are taken 0.5 hours pre-dose and 1, 2, 3, 4, 6, 8, 12 hours post-dose.
A follow-up telephone call is performed 5 days after the study intervention to collect safety data.
Age 18 years or older
Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
Written informed consent
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
Parallel
Rivaroxaban 10 mg Oral Tablet
DrugAdministration of one single dose of rivaroxaban (10 mg) in tablet form.
Apixaban 2.5 mg Oral Tablet
DrugAdministration of one single dose of apixaban (2.5 mg) in tablet form.
Area under the plasma concentration-time curve (AUC) of rivaroxaban
Maximum plasma concentration (Cmax) of rivaroxaban
Time to maximum plasma concentration (tmax) of rivaroxaban
Terminal half-life (t1/2) of rivaroxaban
Cmax of prothrombin fragment (F1+2) after administration of rivaroxaban
tmax of F1+2 after administration of rivaroxaban
Cmax of thrombin-antithrombin-complexes (TAT) after administration of rivaroxaban
tmax of TAT after administration of rivaroxaban
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborator
