Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04874428

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-02-25

24

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

Sponsors

I

Insel Gruppe AG, University Hospital Bern

Lead Sponsor

C

Centre Hospitalier Universitaire Vaudois

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of liver cirrhosis with Child-Pugh score grade A or B
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Positive pregnancy test, pregnancy, or nursing (for women of childbearing age)
  • Use of oral anticoagulants within 2 weeks before study start
  • Use of parenteral anticoagulants within 1 week before study start
  • Use of platelet inhibitors within 2 weeks before study start
  • Known coagulation disorders such as von Willebrand's disease or hemophilia
  • Active or significant bleeding
  • Congenital or acquired bleeding disorders
  • High risk of bleeding including active ulcerative gastrointestinal disease
  • Uncontrolled severe high blood pressure
  • Vascular retinopathy
  • Acute infections including bacterial endocarditis
  • Severe anemia with hemoglobin ≤100 g/L
  • Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Severe liver dysfunction (Child-Pugh score grade C)
  • Hepatic encephalopathy grade 3 or higher
  • Severe kidney impairment with creatinine clearance below 30 ml/min
  • Known intolerance to rivaroxaban or apixaban
  • Use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors/inducers as specified
  • Wash-out period of less than two weeks after use of specified interacting drugs before study drug application

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

D

Dr. med. Guido Stirnimann

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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