Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
Recruiting
Phase 1
Interventional Study
Liver Cirrhosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 24 (estimated)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 o…
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