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NCT Number: NCT07641257

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

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.

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Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Disease Cardiovascular Diseases Chronic Coronary Syndrome Coronary Artery Disease Coronary Disease Heart Diseases Inflammation Myocardial Ischemia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)

    Time frame: 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).

  2. Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)

    Time frame: 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).

  3. Change from Baseline in Lipid Profile Parameters

    Time frame: 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)].

Secondary outcomes

  1. Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling

    Time frame: 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.

  2. Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

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

    Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.

  3. Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

    Time frame: Baseline and 9 or 12 months

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

  4. Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

    Time frame: Baseline and 9/12 months

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

  5. Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

    Time frame: Baseline and 9/12 months

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

  6. Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

    Time frame: Baseline and 9/12 months

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

  7. Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

    Time frame: Baseline and 9/12 months

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

  8. Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

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

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

  9. Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

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

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

  10. Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

    Time frame: 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.

  11. Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation

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

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

Other outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: 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.

  2. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yueying Wang

CONTACT

[email protected]

+86 18202513787

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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