Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Yueying Wang
- Telefonní číslo: +86 18202513787
- E-mail: wangyueying9228@163.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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).
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Control Cohort
Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Časové okno: Baseline, 1 month, 6 months, and 12 months
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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).
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate the changes in cardiovascular and microvascular vulnerability markers, specifically Lipoprotein-associated phospholipase A2 (Lp-PLA2) and Urinary albumin-to-creatinine ratio (UACR).
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in Lipid Profile Parameters
Časové okno: Baseline, 1 month, 6 months, and 12 months
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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)].
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Baseline, 1 month, 6 months, and 12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Časové okno: Baseline, 1 month, 6 months, and 12 months
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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.
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.
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Baseline, 1 month, 6 months, and 12 months
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Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Časové okno: Baseline and 9 or 12 months
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Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)
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Baseline and 9 or 12 months
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Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Časové okno: Baseline and 9/12 months
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Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)
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Baseline and 9/12 months
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Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Časové okno: Baseline and 9/12 months
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Change in Coronary Plaque Area Evaluated by CTA (Unit: mm^2)
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Baseline and 9/12 months
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Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Časové okno: Baseline and 9/12 months
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Change in Degree of Coronary Luminal Stenosis Evaluated by CTA (Unit: percentage)
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Baseline and 9/12 months
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Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Časové okno: Baseline and 9/12 months
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Change in Proportion of Hypoechoic Plaque Components Evaluated by CTA (Unit: percentage)
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Baseline and 9/12 months
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Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate changes in Fasting Blood Glucose (FBG) among participants with a history of diabetes.
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate changes in Insulin (INS) among participants with a history of diabetes.
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) among participants with a history of diabetes.
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Baseline, 1 month, 6 months, and 12 months
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Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Časové okno: Baseline, 1 month, 6 months, and 12 months
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Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes.
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Baseline, 1 month, 6 months, and 12 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Major Adverse Cardiovascular Events (MACE)
Časové okno: Up to 12 months
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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.
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Up to 12 months
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Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Up to 12 months
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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.
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Up to 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Patologické procesy
- Patologické stavy, anatomické
- Srdeční choroba
- Arterioskleróza
- Arteriální okluzivní onemocnění
- Koronární onemocnění
- Ischémie myokardu
- Patologické stavy, příznaky a symptomy
- Zánět
- Ischemická choroba srdeční
- Akutní koronární syndrom
- Komorová remodelace
Další identifikační čísla studie
- 2026-358
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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