Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial
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: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg), high-intensity statin monotherapy (atoravastatin 40mg).
- Кому может быть актуально
- Состояния в реестре: Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation. 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
This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary revascularization with newer generation drug-eluting stent (DES) implantation. Furthermore, the optimal OCT-based optimal expansion criteria as well as the efficacy and safety of newer generation will be investigated.
Подробное описание
All eligible patients who underwent coronary revascularization with newer generation DES implantation will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, we will stratify the patients according to LDL-cholesterol \<100mg/dL, acute coronary syndrome, and DES type, and randomly assign them in two groups according to lipid-lowering therapy with a 1:1 ratio: "Combination therapy group" vs. "Statin monotherapy group". In this study, four types of new generation DES will be used: Orsiro (Biotronik), Firehawk (Microport), Genoss (Genoss) or D+Storm (CGBIO).
In this study, OCT substudy will be performed for the patients with diffuse long lesions requiring total stented length ≥30 mm (targeted for 700 patients in the trial). Corresponding patients will be randomly assigned into two groups according to the OCT-based optimal expansion criteria with a 1:1 ratio: meeting "Absolute expansion" vs. "Relative expansion". The absolute expansion criteria is defined as a minimum stent area (MSA) \>4.5mm2, while the relative expansion criteria is defined as achieving an MSA ≥ 80% of the mean reference lumen area or ≥ 100% of the distal reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy the assigned expansion criteria.
Вмешательства
- Препарат ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg)
The initial dose of lipid-lowering therapy will be ezetimibe 10mg plus atoravastatin 40mg. During follow-up, the dose of ezetimibe 10mg plus atoravastatin 40mg is strongly recommended to be maintained. - Препарат high-intensity statin monotherapy (atoravastatin 40mg)
The initial dose of lipid-lowering therapy will be atoravastatin 40mg. During follow-up, the dose of atoravastatin 40mg is strongly recommended to be maintained.
Первичные конечные точки
- Clinical efficacy of lipid lowering therapy [Срок оценки: Within 3 years after the enrollment]
Вторичные конечные точки (12)
- Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years [Срок оценки: Within 3 years after the enrollment]
- Rate of cross-over into the non-allocated therapy [Срок оценки: Within 3 years after the enrollment]
- Each component of primary endpoint A. All-cause death (percentage) [Срок оценки: Within 3 years after the enrollment]
- Each component of primary endpoint B. MI (percentage) [Срок оценки: Within 3 years after the enrollment]
- Each component of primary endpoint C. Any coronary revascularization (percentage) [Срок оценки: Within 3 years after the enrollment]
- Each component of primary endpoint D. Hospitalization for unstable angina (percentage) [Срок оценки: Within 3 years after the enrollment]
- Each component of primary endpoint E. Nonfatal-stroke (percentage) [Срок оценки: Within 3 years after the enrollment]
- Cardiac death (percentage) [Срок оценки: Within 3 years after the enrollment]
- Stent thrombosis (percentage) [Срок оценки: Within 3 years after the enrollment]
- Target-vessel revascularization (percentage) [Срок оценки: Within 3 years after the enrollment]
- Target-lesion revascularization (percentage) [Срок оценки: Within 3 years after the enrollment]
- BARC type 2-5 bleeding (percentage) [Срок оценки: Within 3 years after the enrollment]
Критерии участия
Критерии включения
- Age 19-85 years
- Patients who underwent coronary revascularization with newer generation DES implantation
Критерии исключения
- Allergy or hypersensitive to ezetimibe or statin
- Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- History of any adverse drug reaction requiring discontinuation of statin
- Pregnant women, women with potential childbearing, or lactating women
- Life expectancy less than 3 years
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed consent
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
- Открытое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Yonsei University Health System, Severance Hospital — Seoul
Идентификаторы
NCT: NCT05782777 · 4-2022-1335