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

N/ANot Yet RecruitingNCT07641257

Ruijin Hospital420 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

420

Conditions

Acute Coronary Syndromes (ACS)Chronic Coronary Syndrome Coronary Artery Disease Atherosclerosis Cardiovascular Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline, 1 month, 6 months, and 12 months

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).

Time frame: Baseline, 1 month, 6 months, and 12 months

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) \[Lp(a)\].

Time frame: Baseline, 1 month, 6 months, and 12 months

Secondary Outcomes

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.

Time frame: Baseline, 1 month, 6 months, and 12 months

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.

Time frame: Baseline, 1 month, 6 months, and 12 months

Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)

Time frame: Baseline and 9 or 12 months

Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)

Time frame: Baseline and 9/12 months

Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

Change in Coronary Plaque Area Evaluated by CTA (Unit: mm\^2)

Time frame: Baseline and 9/12 months

Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

Change in Degree of Coronary Luminal Stenosis Evaluated by CTA (Unit: percentage)

Time frame: Baseline and 9/12 months

Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

Change in Proportion of Hypoechoic Plaque Components Evaluated by CTA (Unit: percentage)

Time frame: Baseline and 9/12 months

Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

Evaluate changes in Fasting Blood Glucose (FBG) among participants with a history of diabetes.

Time frame: Baseline, 1 month, 6 months, and 12 months

Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

Evaluate changes in Insulin (INS) among participants with a history of diabetes.

Time frame: Baseline, 1 month, 6 months, and 12 months

Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

Evaluate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) among participants with a history of diabetes.

Time frame: Baseline, 1 month, 6 months, and 12 months

Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes.

Time frame: Baseline, 1 month, 6 months, and 12 months

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

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts