Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
8 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
De observación
Inscripción (Estimado)
420
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yueying Wang
- Número de teléfono: +86 18202513787
- Correo electrónico: wangyueying9228@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de mayo de 2026
Finalización primaria (Estimado)
30 de mayo de 2028
Finalización del estudio (Estimado)
30 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Condiciones Patológicas, Anatómicas
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Condiciones Patológicas, Signos y Síntomas
- Inflamación
- Enfermedad de la arteria coronaria
- El síndrome coronario agudo
- Remodelación Ventricular
Otros números de identificación del estudio
- 2026-358
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .