Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis

Recruiting now · Phase 1

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT04874428

Run by

Insel Gruppe AG, University Hospital Bern

People needed

24

Starts

2021-05-19

Expected to finish

2026-06-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 is running

• Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne — Bern, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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