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Набор скоро начнётся NCT06683131

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

Фаза IV С лечением Acute Myocardial Infarction (AMI)

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: Tafolecimab.
Кому может быть актуально
Состояния в реестре: Acute Myocardial Infarction (AMI). Базовые параметры: 18 лет — 75 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

IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial

Обзор

The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are: * Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events? * Does drug tafolecimab improve the coronary microvascular dysfunction? * What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI. Participants will: * Administer drug tafolecimab by injection or not every month for 12 months * Receive the standard of care of AMI * Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI * Complete cardiac magnetic resonance after PCI if available * Visit the clinic at 1,6,12 months after the first administration for checkups and tests * Report any discomfort, event or queries at any time

Вмешательства

  • Препарат Tafolecimab
    450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months.

Первичные конечные точки

  • Rate of major adverse cardiovascular events (MACEs) [Срок оценки: From enrollment to 1 year after primary percutaneous coronary intervention]
Вторичные конечные точки (4)
  • Number of participants with coronary microvascular dysfunction (CMD) [Срок оценки: Immediately after primary percutaneous coronary intervention]
  • Number of participants with coronary microvascular dysfunction (CMD) [Срок оценки: 3-7 days after primary percutaneous coronary intervention]
  • Concentration of low density lipoprotein cholesterol (LDL-C) [Срок оценки: Both 1 month and 1 year after primary percutaneous coronary intervention]
  • Rate of malignant arrhythmia [Срок оценки: 1 month after primary percutaneous coronary intervention]

Критерии участия

Критерии включения

  • Adults 18-75 years old
  • AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)
  • The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.
  • The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .
  • Regardless of baseline LDL-C levels
  • Participants voluntarily took part in this study and signed informed consent

Критерии исключения

  • Previous or ongoing treatment for any PCSK9i
  • Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
  • History of hemorrhagic cerebrovascular disease
  • History of old myocardial infarction/chronic heart failure
  • History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
  • Above Killip level II
  • Prolonged cardiopulmonary resuscitation (>20min)
  • Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)
  • malignant arrhythmia
  • Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors
  • Pregnant or lactating women
  • Participate in other clinical trials

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 · 13 центров
  • Taihe County People's Hospital — Fuyang
  • The Fifth People's Hospital of Huai'an City — Huai'an
  • Lianyungang Municipal Dongfang Hospital — Lianyungang
  • Jiangsu Provincial Hospital of Traditional Chinese Medicine — Нанкин
  • Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical Uni — Нанкин
  • The Fourth Affiliated Hospital of Nanjing Medical University — Нанкин
  • Suqian Hospital of Jiangsu Provincial People's Hospital — Suqian
  • The affiliated hospital of Xuzhou Medical University — Xuzhou
  • … и ещё 5 центров

Идентификаторы

NCT: NCT06683131 · XYFY2024-KL537-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗