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Набор скоро начнётся NCT07129850

Bempedoic Acid in PPCI Impact on Clinical Outcome and Inflammatory Markers

Наблюдательное ST Elevation (STEMI) 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: ST Elevation (STEMI) Myocardial Infarction. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Bempedoic Acid in Primary Percutaneous Coronary Intervention: Impact on Inflammatory Markers, Procedural and Clinical Outcomes

Обзор

Bempedoic acid in PPCI

Подробное описание

Cardiovascular disease persists as the predominant cause of global burden of mortality and morbidity worldwide(1).

The cholesterol hypothesis posits that elevated blood cholesterol levels constitute a significant risk factor for atherosclerotic cardiovascular disease (ASCVD) and reducing cholesterol levels will consequently lower the risk of ASCVD(2).

Treatments aimed at lowering lipid levels have demonstrated their effectiveness in decelerating the advancement of atherosclerotic disease(3). This finding further reinforces the pathophysiological connections between plasma lipids and the progression of CAD. Among non-lipid mechanisms involved in reducing CAD progression, lipid-lowering drugs have also been implicated in plaque stabilization, reduced inflammation, reversal of endothelial dysfunction, and decreased thrombogenicity(3).

It is widely accepted that the beneficial effects of statins on cardiovascular events are mainly linked to their cholesterol lowering properties. Nonetheless, statins also have a clear action in reducing systemic inflammation. The effect on hsCRP is proportionally similar to that on LDL-C(4).

It is known that an anti-inflammatory action contributes to the reduction of cardiovascular risk independently of the effect on LDL-C. Four-year therapy with canakinumab, a specific anti-interleukin-1b monoclonal antibody, in patients with previous myocardial infarction reduced the relative risk of relapse by approximately 15% by reducing hsCRP levels by 60% without modifying LDL-C(5). It is therefore possible to hypothesize that cholesterol lowering drugs with an effect on hsCRP, such as statins and bempedoic acid, have advantages in reducing cardiovascular events compared to those that do not act on inflammation, such as PCSK9 inhibitors(4).

Bempedoic acid is a new cholesterol-lowering drug, which has recently received US FDA approval. It offers a safe and effective oral therapeutic option for lipid lowering in patients who cannot tolerate statins or in addition to statins in patients who are not reaching the LDL target(6). Bempedoic acid targets lipid and glucose metabolism as well as inflammation. The primary effect is the reduction of cholesterol synthesis in the liver and its administration is generally not associated to unwanted muscle effects(4).

Bempedoic acid may decrease gluconeogenesis leading to improved insulin sensitivity, glucose metabolism, and metabolic syndrome(4).

The anti-inflammatory action of bempedoic acid is mainly achieved via activation of AMPK pathway in the immune cells, leading to decreased plasma levels of C-reactive protein(4).

However, its potential role in modulating post-PCI inflammatory response has not been fully investigated, especially in primary PCI setting.

Первичные конечные точки

  • Change in inflammatory markers [Срок оценки: At 1 month post-PCI.]
Вторичные конечные точки (3)
  • Final TIMI flow grade post-PCI. [Срок оценки: 1 day]
  • Major Adverse Cardiac Events [Срок оценки: Within 30 days post-PCI.]
  • Lipid Profile Changes [Срок оценки: At 1 month post-PCI.]

Критерии участия

Критерии включения

Age ≥18 years STEMI diagnosis Undergoing primary PCI

Критерии исключения

Known allergy to Bempedoic acid Active infection or chronic inflammatory disease Severe hepatic or renal dysfunction Use of immunosuppressive therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662. PMID 30922146
  • Ridker PM, Everett BM, Thuren T, MacFadyen JG, Chang WH, Ballantyne C, Fonseca F, Nicolau J, Koenig W, Anker SD, Kastelein JJP, Cornel JH, Pais P, Pella D, Genest J, Cifkova R, Lorenzatti A, Forster T, Kobalava Z, Vida-Simiti L, Flather M, Shimokawa H, Ogawa H, Dellborg M, Rossi PRF, Troquay RPT, Libby P, Glynn RJ; CANTOS Trial Group. Antiinflammatory Therapy with Canakinumab for Atherosclerotic D PMID 28845751
  • Biolo G, Vinci P, Mangogna A, Landolfo M, Schincariol P, Fiotti N, Mearelli F, Di Girolamo FG. Mechanism of action and therapeutic use of bempedoic acid in atherosclerosis and metabolic syndrome. Front Cardiovasc Med. 2022 Oct 28;9:1028355. doi: 10.3389/fcvm.2022.1028355. eCollection 2022. PMID 36386319
  • Feingold KR. Guidelines for the Management of Dyslipidemia. 2026 May 4. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, PMID 26247090
  • WHO CVD Risk Chart Working Group. World Health Organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions. Lancet Glob Health. 2019 Oct;7(10):e1332-e1345. doi: 10.1016/S2214-109X(19)30318-3. Epub 2019 Sep 2. PMID 31488387

Идентификаторы

NCT: NCT07129850 · Bempedoic acid in PPCI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗