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Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling

8 de junho de 2026 atualizado por: Ruijin Hospital

Impact of Icosapent Ethyl on Ventricular Remodeling, Inflammation, and Coronary Plaque Stability in Patients With Acute or Chronic Coronary Syndrome: A Prospective, Observational, Real-World Study

Even with standard treatments like statins, patients with coronary artery disease often face a residual risk of further heart events. This risk is largely driven by ongoing inflammation and unstable fatty plaques in the heart's blood vessels. Icosapent ethyl (IPE) is a highly purified prescription medication known to improve cardiovascular outcomes, but its detailed effects on the heart's structure and inflammation in everyday clinical practice need further exploration.

This study is a prospective, observational, real-world study designed to evaluate the effectiveness of IPE in patients with Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS). The study plans to enroll 420 patients who will be followed for 12 months. Based on their routine clinical prescriptions, participants will be grouped into a control group (receiving standard cardiovascular care, including statins) and an exposure group (receiving standard care plus IPE).

Throughout the 1-year follow-up, researchers will conduct regular blood tests and advanced heart imaging. The main goal is to determine if adding IPE to standard therapy leads to a more significant reduction in inflammation. Additionally, the study will observe how IPE affects the stability of coronary plaques and the healing process of ventricular remodeling in a real-world clinical setting.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

420

Contactos e Locais

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Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population consists of adult patients (aged 18 years and older) diagnosed with either acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) who present to the cardiology inpatient wards or outpatient clinics of the participating medical centers. These are real-world patients who have elevated fasting triglyceride levels (>= 1.7 mmol/L) and are routinely receiving standard-of-care cardiovascular therapies, including statin therapy. Depending on their routine clinical prescriptions determined by their treating physicians, they are either receiving Icosapent ethyl (IPE) as an add-on therapy or continuing with standard of care alone.

Descrição

Inclusion Criteria:

  • Age 18 years and older, of any sex.

    • Definite diagnosis of chronic coronary syndrome (CCS) according to the Chinese Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome, or acute coronary syndrome (ACS) according to the 2025 ACC/AHA/ACEP/NAEMSP/SACI Guideline for the Management of Acute Coronary Syndromes.
    • Laboratory evaluation showing fasting triglycerides (TG) >= 1.7 mmol/L.
    • Ability to fully understand the study purpose, voluntary participation, and provision of signed written informed consent.

Exclusion Criteria:

  • Women who are planning a pregnancy, currently pregnant, or lactating.

    • Known hypersensitivity or allergic reaction to the active ingredient of icosapent ethyl (IPE) or any of its excipients (applicable to patients in the exposure cohort).
    • Diagnosed with major life-threatening conditions such as malignant tumors, end-stage lung disease, or advanced neurodegenerative diseases, with a life expectancy of less than 12 months.
    • Concurrent participation in any other interventional clinical trial involving investigational drugs or medical devices.
    • Any other condition or severe non-compliance that, in the judgment of the investigator, makes the patient unsuitable for enrollment in this study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Exposure Cohort
atients with acute or chronic coronary syndrome who are prescribed Icosapent ethyl (IPE) in addition to their standard of care (including statin therapy).
Control Cohort
Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate the relative and absolute changes in systemic inflammation and cardiac stress markers, including high-sensitivity C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and soluble suppression of tumorigenicity 2 (sST2).
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate the changes in cardiovascular and microvascular vulnerability markers, specifically Lipoprotein-associated phospholipase A2 (Lp-PLA2) and Urinary albumin-to-creatinine ratio (UACR).
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Lipid Profile Parameters
Prazo: Baseline, 1 month, 6 months, and 12 months
Assess changes in lipid metabolism parameters, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), Apolipoprotein A1 (ApoA1), Apolipoprotein B (ApoB), and Lipoprotein(a) [Lp(a)].
Baseline, 1 month, 6 months, and 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate structural and functional changes of the left ventricle by calculating Left Ventricular End-Diastolic Volume (LVEDV) and Left Ventricular End-Systolic Volume (LVESV) via transthoracic echocardiography.
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.
Baseline, 1 month, 6 months, and 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Prazo: Baseline and 9 or 12 months
Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)
Baseline and 9 or 12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Prazo: Baseline and 9/12 months
Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)
Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Prazo: Baseline and 9/12 months
Change in Coronary Plaque Area Evaluated by CTA (Unit: mm^2)
Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Prazo: Baseline and 9/12 months
Change in Degree of Coronary Luminal Stenosis Evaluated by CTA (Unit: percentage)
Baseline and 9/12 months
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Prazo: Baseline and 9/12 months
Change in Proportion of Hypoechoic Plaque Components Evaluated by CTA (Unit: percentage)
Baseline and 9/12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate changes in Fasting Blood Glucose (FBG) among participants with a history of diabetes.
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate changes in Insulin (INS) among participants with a history of diabetes.
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) among participants with a history of diabetes.
Baseline, 1 month, 6 months, and 12 months
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Prazo: Baseline, 1 month, 6 months, and 12 months
Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes.
Baseline, 1 month, 6 months, and 12 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Major Adverse Cardiovascular Events (MACE)
Prazo: Up to 12 months
Assess the between-group differences in the composite incidence of MACE, defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, heart failure hospitalization, and unplanned revascularization.
Up to 12 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Up to 12 months
Safety endpoint evaluating the occurrence of all-cause adverse events, serious adverse events, and specific safety events of interest (including clinical bleeding events) during the study medication period.
Up to 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ruijin Hospital

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de maio de 2026

Conclusão Primária (Estimado)

30 de maio de 2028

Conclusão do estudo (Estimado)

30 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-358

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

De-identified individual participant data (IPD) that underlie the results reported in the primary publication, along with the study protocol and statistical analysis plan, will be shared.

Data will be available upon reasonable request to the Principal Investigator, beginning 6 months and ending 36 months following article publication.

To gain access, researchers must submit a methodologically sound proposal for secondary analysis or meta-analysis. The proposal will be reviewed by the study steering committee. If approved, data sharing will be strictly subject to a formal data-sharing agreement and must comply with the ethical regulations of the participating institutions. No specific IPD will be shared unconditionally.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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