Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Edoxaban, Apixaban.
- Кому может быть актуально
- Состояния в реестре: Patients With Atrial Fibrillation and Cornary Artery Disease. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Non-vitamin K antagonist oral anticoagulants (NOACs) have become the standard of care for the prevention of thromboembolic events in patients with AF. In patients with AF and concomitant CAD, the choice of oral anticoagulant is particularly important because clinicians must balance the risks of thromboembolism, coronary ischemic events, as well as bleeding. Among available NOACs, apixaban and edoxaban share a common mechanism of factor Xa inhibition but differ substantially in dosing regimen, pharmacokinetic profile, and degree of renal elimination. In the recent COBRRA trial, apixaban was associated with significantly lower clinically relevant bleeding compared with rivaroxaban in patients with acute venous thromboembolism, without compromising efficacy against recurrent thromboembolism. Although these data support apixaban as an important benchmark NOAC, direct randomized comparisons between edoxaban and apixaban are lacking, particularly in patients with AF and coexisting CAD. Once-daily dosing and lower renal elimination fraction of edoxaban may offer practical advantages, particularly in elderly patients or those with impaired renal function, by potentially improving adherence and simplifying dose adjustment. Whether these pharmacological differences translate into meaningful differences in overall clinical outcomes remains uncertain. Given that anticoagulation strategies inherently require balancing thromboembolic protection against bleeding risk, evaluation using a net clinical outcome is clinically most relevant. Therefore, this randomized controlled trial is designed to determine whether edoxaban-based therapy is non-inferior to apixaban with respect to NACE, a composite of death, thromboembolic, and major bleeding outcomes in patients with AF and concomitant CAD.
Вмешательства
- Препарат Edoxaban
Edoxaban 60mg will be administered once daily orally according to the study protocol. - Препарат Apixaban
Apixaban 5mg will be administered twice a day orally according to the study protocol.
Первичные конечные точки
- Net Adverse Clinical Events (NACE) [Срок оценки: 5 years]
Вторичные конечные точки (1)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACEE) [Срок оценки: 5 years]
Критерии участия
Критерии включения
i) Patients must be at least 19 years of age ii) Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VaSc 2 or more) iii) Documented coronary artery disease, defined as at least one of the following:
- history of percutaneous coronary intervention (PCI)
- history of coronary artery bypass grafting (CABG)
- major epicardial coronary artery stenosis ≥50% on coronary computed tomography angiography (CCTA) or invasive coronary angiography iv) Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Критерии исключения
i) Known hypersensitivity or contraindications to study medications (apixaban or edoxaban) ii) Severe renal impairment (creatinine clearance <15 mL/min) or dialysis iii) Active major bleeding iv) Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate / severe mitral stenosis) v) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment) vi) Pregnant or lactating women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Samsung Medical Center — Seoul
Идентификаторы
NCT: NCT07753200 · SMC 2026-05-061