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Идёт набор NCT05292404

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

Фаза IV С лечением 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: alirocumab, conventional treatment.
Кому может быть актуально
Состояния в реестре: Acute Myocardial Infarction. 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 Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial

Обзор

This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.

Вмешательства

  • Препарат alirocumab
    In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months
  • Другое conventional treatment
    conventional treatment were given according to international uniformguidelines

Первичные конечные точки

  • myocardial salvage index [Срок оценки: 1 week after operation]
Вторичные конечные точки (1)
  • Eject fraction [Срок оценки: at 6 months after operation]

Критерии участия

Критерии включения

  • The age is greater than 18 years old and less than or equal to 80 years old.
  • Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
  • Signed informed consent.

Критерии исключения

  • Patients who are allergic to PCSK9 inhibitors.
  • Multivessel disease planned for selective intervention within half a year.
  • Patients who have previously undergone revascularization.
  • Pregnant women or women who plan to become pregnant in the next 2 years.
  • Patients whose life expectancy is less than 1 year.
  • Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
  • Known active malignant tumor diseases.
  • Patients considered by the investigator to be unsuitable to participate in this 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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 5 центров
  • nineth people's hospital, School of Medicine, shanghai jiaotong university — Шанхай
  • Shanghai chest hospital — Шанхай
  • Shanghai tongren hospital — Шанхай
  • tenth people's hospital, tongji university, Shanghai — Шанхай
  • Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай

Публикации

  • Xia J, Wang X, Zhou J, Wang D, Pang Y, Xu X, Sang Z, Zhang Y, Zhang J, Wu S, Xiao Z, Hou L. Impact of early PCSK9 inhibitor treatment on heart after percutaneous coronary intervention in patients with STEMI: Design and rationale of the PERFECT II trial. Front Cardiovasc Med. 2022 Sep 23;9:1009674. doi: 10.3389/fcvm.2022.1009674. eCollection 2022. PMID 36211588

Идентификаторы

NCT: NCT05292404 · ShanghaiTRH-HL2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗