NCT04874428 Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
| NCT ID | NCT04874428 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2021-05-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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.
Contact & Investigator
Dr. med. Guido Stirnimann
PRINCIPAL INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT04874428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04874428 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04874428 currently recruiting?
Yes, NCT04874428 is actively recruiting participants. Contact the research team at guido.stirnimann@insel.ch for enrollment information.
Where is the NCT04874428 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT04874428 clinical trial?
NCT04874428 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Dr. med. Guido Stirnimann at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 24 participants.