Status:
RECRUITING
Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Centre Hospitalier Universitaire Vaudois
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 enr...
Detailed Description
Background: Cirrhosis is an increasing cause of morbidity and mortality in more developed countries, being the 14th most common cause of death worldwide but fourth in central Europe. Patients with li...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Patient with previously diagnosed liver cirrhosis (Child-Pugh score grade A and B).
- Written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04874428
Start Date
May 19 2021
End Date
June 1 2026
Last Update
December 24 2024
Active Locations (1)
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1
Department of Visceral Surgery and Medicine, University Hospital Inselspital, Berne
Bern, Switzerland, 3010