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.
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.
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.
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.
Cohort
Prospective
Not listed
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
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).
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Evaluate the changes in cardiovascular and microvascular vulnerability markers, specifically Lipoprotein-associated phospholipase A2 (Lp-PLA2) and Urinary albumin-to-creatinine ratio (UACR).
Change from Baseline in Lipid Profile Parameters
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) \[Lp(a)\].
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
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.
Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)
Major Adverse Cardiovascular Events (MACE)
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.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
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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