Nonvalvular Atrial Fibrillation MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Lixiana
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Edoxaban
CAS Number: 480449-70-5
Other descriptive name: EDOXABAN
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients aged 18 - 89 years - Non-valvular atrial fibrillation - Indication for initiation of oral anticoagulation therapy - Cockcroft-Gault CreaCl 15 ml/min or higher - CHA2DS2-VASc risk score = 2 (men) or = 3 (women) - hospitalisation for reasons other than mere participation in this study - Body weight from =60 kg to =125 kg during screening - Written informed consent - For women of childbearing potential: consent to the use of highly effective contraception (Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: - Cockcroft-Gault CreaCl < 15ml/min, unstable kidney function and/or need for renal replacement therapy - Presence of a functional kidney transplant - Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal product - Clinically relevant, active bleeding - Hepatic Disease associated with coagulopathy and clinically relevant bleeding risk - Liver cirrhosis Child-Pugh stage C - lesion or condition that may put the patient at significant risk for major bleeding, including but not limited to: - Acute or recent (< 1 month) gastrointestinal ulceration, - Malignant neoplasms at high risk of bleeding, - Recent (< 1 month) brain or spinal injuries, - Recent (< 1 month) brain, spinal or ophthalmic surgery, - Recent (< 1 month) intracranial hemorrhage, - Known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities - Uncontrolled, severe arterial hypertension - Current use (up to 7 days before screening) of NOAC or VKA - Simultaneous systemic use of heparin or its derivatives (UFH, low molecular weight heparins, Fondaparinux, etc.) except under special circumstances of switching to oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter - Simultaneous systemic use of NSAIDs - Pregnancy and lactation - Co-treatment with one of the P-glycoprotein inhibitors Ciclosporin, Dronedarone, Erythromycin, Ketoconazole within the last 14 days, except for topical use - Co-treatment with one of the P-glycoprotein inducers Apalutamid, Carbamazepin, Enzalutamid, Johanniskraut, Letermovir, Phenobarbital, Phenytoin, Pitolisant, Rifampicin within the last 14 days - Inability to understand study procedures and to give informed consent - Persons who due to judicial or administrative arrangement are housed in an institution - Simultaneous participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to analyse the pharmacokinetics (PK) of Edoxaban with reduced dose (30 mg once daily) in CKD patients with Cockcroft-Gault CreaCl 15 - 29 ml/min (group 1) and CKD patients with Cockcroft-Gault CreaCl 30 - 49 ml/min (group 2, experimental groups) each compared to normal dose (60 mg once daily) in patients with Cockcroft-Gault CreaCl = 50 ml/min (group 3, control group).;Secondary Objective: The secondary objective is to investigate the safety profile of the therapy, regarding (Serious) Adverse events.;Primary end point(s): Edoxaban AUC0-24 in steady-state (visit 3) The visit 3 can already take place from day 5 for patients in group 2 (CreaCl 30 - 49 ml/min) and from day 4 for patients in group 3 (CreaCl = 50 ml/min).;Timepoint(s) of evaluation of this end point: Day 6 of study therapy Optional: from day 5 for patients in group 2 (CreaCl 30 - 49 ml/min) and from day 4 for patients in group 3 (CreaCl = 50 ml/min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pharmacokinetic parameters of Edoxaban and the active M4 metabolites - Adverse Events, Serious Adverse Events, Bleeding Events ;Timepoint(s) of evaluation of this end point: - Day 1 (visit 1), 6 (visit 3, optional for group 2 from day 5 and for group 3 grom day 4) and 14 (visit 4): pharmacokinetic parameters of Edoxaban and the active M4 metabolites - Throughout the entire study therapy, day 1 to 14: adverse events, serious adverse events, bleeding events | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Universitätsklinikum Halle
Outcome results
None listed