Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction
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: Aspirin, Shexiang Baoxin Pill.
- Кому может быть актуально
- Состояния в реестре: Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI). Базовые параметры: от 18 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction: A Prospective, Multicenter, Pragmatic Randomized Controlled Real-World Study
Обзор
This study aims to evaluate the value of Shexiang Baoxin Pill (MUSKARDIA) in patients with acute myocardial infarction (AMI) through a prospective, multicenter, pragmatic randomized controlled real-world study. It seeks to validate its efficacy in reducing cardiovascular event risk during the peri-PCI period, as well as its effects on cardiac function, quality of life , and relevant biomarkers. Through this research, we expect to provide higher-quality evidence for the application of SBP in AMI patients undergoing PCI, thereby further optimizing comprehensive treatment strategies for AMI.
Вмешательства
- Препарат Aspirin
Patients in the Shexiang Baoxin Pill(MUSKARDI) group initiated treatment immediately after randomization. They received 2-4 pills of Shexiang Baoxin Pill preoperatively before PCI, followed by a maintenance dose of 2-4 pills orally three times daily (TID) with warm water for 12 months postoperatively, concurrently with standard guideline-directed therapy. - Препарат Shexiang Baoxin Pill
Patients in the Shexiang Baoxin Pill group initiated treatment immediately after randomization. They received 2-4 pills of Shexiang Baoxin Pill preoperatively before PCI, followed by a maintenance dose of 2-4 pills orally three times daily (TID) with warm water for 12 months postoperatively, concurrently with standard guideline-directed therapy.
Первичные конечные точки
- Incidence of major adverse cardiovascular and cerebrovascular events (MACE) [Срок оценки: 1 year after PCI]
Вторичные конечные точки (9)
- Incidence of non-fatal myocardial infarction [Срок оценки: 1 year after PCI]
- Incidence of non-fatal stroke [Срок оценки: 1 year after PCI]
- Rehospitalization rate due to angina pectoris [Срок оценки: 1 year after PCI]
- Rate of unplanned revascularization [Срок оценки: 1 year after PCI]
- Cardiac mortality rate [Срок оценки: 1 year after PCI]
- Rehospitalization rate due to heart failure [Срок оценки: 1 year after PCI]
- All-cause mortality rate [Срок оценки: 1 year after PCI]
- Seattle Angina Questionnaire score [Срок оценки: 1 year after PCI]
- EQ-5D-5L scale [Срок оценки: 1 year after PCI]
Критерии участия
Критерии включения
- Aged 18 years or older, regardless of gender
- In accordance with the 2023 ESC Guidelines for the Management of Acute Coronary Syndromes , meeting the diagnostic criteria for acute myocardial infarction, including typical chest pain lasting for ≥20 minutes, electrocardiographic manifestations of ST-segment elevation (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), and serum high-sensitivity troponin (hs-cTn) levels exceeding the 99th percentile of the upper reference limit at least once with dynamic changes
- Presenting for treatment within <24 hours of symptom onset and scheduled to undergo PCI
- The patient or their guardian has signed the informed consent form
Критерии исключения
- Having contraindications to PCI treatment
- Being allergic to Shexiang Baoxin Pills, unable to tolerate them, or having other conditions that prevent completion of the trial drug administration
- Being pregnant, planning to become pregnant, or breastfeeding women
- Having participated in other clinical studies within 3 months
- Being deemed unsuitable for inclusion in this study by the researcher
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
Китай · 1 центр
- Zhongshan Hospital, Fudan University — Шанхай
Идентификаторы
NCT: NCT07153744 · HMPE202501