Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
607
Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.
Pharmacokinetics: Average Concentration of Edoxaban at Steady State (Cav)
In pharmacokinetics, steady state means the overall intake of a drug is about equal to its elimination
Time frame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacokinetics: Minimum Concentration of Edoxaban in Plasma (Cmin)
Cmin is a term used in pharmacokinetics that usually refers to the minimum blood plasma concentration that a drug achieves after the drug has been administered and prior to the administration of a second dose
Time frame: After initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure using validated assays
Exposure analysis performed with validated Liquid Chromatography/Tandem Mass Spectrometry/Mass Spectrometry (LC/MS/MS) assay with lithium heparin plasma. Categories: Edoxaban and its metabolite (D21-2393)
Time frame: Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Pharmacodynamics: Mean exposure with anti-Factor Xa (FXa) assay
Exposure analysis performed with anti-FXa assay, using sodium citrate plasma samples Categories: Edoxaban and D21-2393
Time frame: Pre-dose and after initiation of dosing on Days 30, 90, and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose)
Efficacy: Number of participants with composite event 1
Composite event 1 includes ischemic or hemorrhagic stroke/transient ischemic attack (TIA) and systemic embolic events (SEE)
Time frame: within 3 years
Efficacy: Number of participants with composite event 2
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Composite event 2 includes stroke/TIA, SEE, myocardial infarction, cardiovascular death, and major bleeding
Time frame: within 3 years
Safety: Number of participants with major bleeding (including intracranial)
Major bleeding is defined per the International Society on Thrombosis and Haemostasis (ISTH) definition
Time frame: within 3 years
Safety: Number of participants with clinically relevant bleeding
Clinically relevant bleeding is a combination of major bleeding and clinically relevant non-major (CRNM) bleeding
Time frame: within 3 years
Safety: Number of participants with any bleeding
Count of participants who experienced any bleeding event
Time frame: within 3 years