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Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
Sponsor: Insel Gruppe AG, University Hospital Bern
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.
Official title: Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2021-05-19
Completion Date
2026-06
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Rivaroxaban 10 mg Oral Tablet
Administration of one single dose of rivaroxaban (10 mg) in tablet form.
Apixaban 2.5 mg Oral Tablet
Administration of one single dose of apixaban (2.5 mg) in tablet form.
Locations (1)
Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne
Bern, Switzerland