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

Official 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

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.

Primary outcome measures

• Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2) [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR) [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in Lipid Profile Parameters [Time frame: Baseline, 1 month, 6 months, and 12 months]

Secondary outcome measures (11)

• Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA [Time frame: Baseline and 9 or 12 months]
• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA [Time frame: Baseline and 9/12 months]
• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA [Time frame: Baseline and 9/12 months]
• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA [Time frame: Baseline and 9/12 months]
• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA [Time frame: Baseline and 9/12 months]
• Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation [Time frame: Baseline, 1 month, 6 months, and 12 months]
• Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation [Time frame: Baseline, 1 month, 6 months, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10. PMID 30415628

Identifiers

NCT: NCT07641257 · 2026-358

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗