Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated February 25, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-04-30; most recent amendment 2026-02-23.
Status change: Not Yet Recruiting → Recruiting 2021-05-12
Trial Details
NCT Number NCT04874428
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: Centre Hospitalier Universitaire Vaudois
Conditions Liver Cirrhosis
Enrollment 24 participants
Start Date 2021-05-19
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-25