A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI

Официальное название

A Randomized Controlled Trial on the Efficacy and Safety of Butylphthalide in Reducing Myocardial Infarction Size and Improving Outcomes in STEMI Patients After Primary PCI - A Prospective, Multicenter, Randomized, Placebo, Double-blinded End Trial.

Обзор

This study is a prospective, randomized, placebo-double-blind, multicenter clinical trial. The purpose of this study is to investigate whether "butylphthalide +PCI" combined treatment mode on the basis of traditional drug therapy could reduce myocardial infarct size, improve cardiac function and long-term prognosis of patients with acute myocardial infarction, and verify the drug safety of butylphthalide in the treatment of STEMI within the window period of 12 hours.

Вмешательства

• Препарат Butylphthalide
  Subjects who were initially diagnosed with STEMI and scheduled for PCI were randomly assigned to one of two groups in a 1:1 ratio: a butylphthalide group and a placebo group.
• Препарат Butylphthalide placebo
  Butylphthalide placebo

Первичные конечные точки

• The efficacy in reducing myocardial infarct size in subjects with STEMI after primary PCI [Срок оценки: 30±2 days post-randomization]

Вторичные конечные точки (5)

• The proportion of no-reflow and severe slow flow events [Срок оценки: 30±2 days post-randomization]
• The changes of ST-segment resolution in electrocardiogram [Срок оценки: 7±2 days and 30±2 days post-randomization]
• CMR imaging cardiac function indexes and cardiac color Doppler ultrasound related indexes [Срок оценки: 30±2 days post-randomization]
• The decline of myocardial enzyme indexes [Срок оценки: 7±2 days and 30±2 days post-randomization]
• Proportion of combined vascular events [Срок оценки: 30±2 days post-randomization]

Критерии участия

Критерии включения

• Age range of 18-75 years, encompassing both genders;
• Patients presenting with an initial clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI), within a maximum time frame of 12 hours from the onset of pain to consideration for trial inclusion, who fulfill the criteria for percutaneous coronary intervention (PCI) and express their intention to undergo PCI;
• The subject and their legal representative possess the capacity and willingness to provide informed consent by signing.

Критерии исключения

• Uncontrolled hypertension (systolic blood pressure≥200mmHg and/or diastolic blood pressure≥110mmHg);
• Previous PCI or CABG;
• Long-term use of loading doses of anticoagulant or antiplatelet drugs;
• History of hemorrhagic stroke or ischemic stroke within 6 months, peptic ulcer, prolonged cardiopulmonary resuscitation (more than 10 minutes) within the last 6 weeks, surgery, or major trauma;
• Known allergy to butylphthalide or excipients;
• Patients with any of the following conditions: cardiogenic shock, chronic congestive heart failure NYHA class ≥III, severe hypotension, pulmonary insufficiency, severe hepatic and renal insufficiency;
• History of congenital or acquired hemorrhagic diseases, coagulation factor deficiency diseases, thrombocytopenic diseases, etc. Or any of the following laboratory tests (INR > 2.0, platelet count < 100×109/L, Hb < 10g/dl);
• Pregnancy, lactation, and planning to become pregnant within 30 days;
• Severe mental disorder, alcohol dependence or inability to cooperate with informed consent and follow-up due to dementia;
• Concurrent malignant tumor or severe systemic disease with expected survival time less than 30 days;
• Have participated in or are currently participating in another clinical intervention study within 30 days before randomization;
• Other reasons for not being eligible for the study.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06704685 · 202409176

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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