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

NCT07641257 | Not Yet Recruiting

• 1 other identifier: 2026-358
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Coronary Syndromes (ACS); Chronic Coronary Syndrome; Coronary Artery Disease; Atherosclerosis Cardiovascular Disease; Ventricular Remodeling; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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) \[Lp(a)\].

  Baseline, 1 month, 6 months, and 12 months

Secondary Outcomes (11)

• Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling

  Baseline, 1 month, 6 months, and 12 months

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

  Baseline, 1 month, 6 months, and 12 months

• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

  Baseline and 9 or 12 months

• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

  Baseline and 9/12 months

• Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA

  Baseline and 9/12 months

Other Outcomes (2)

• Major Adverse Cardiovascular Events (MACE)

  Up to 12 months

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 12 months

Study Arms (2)

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).

Control Cohort

Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Ventricular Remodeling; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Yueying Wang

CONTACT

+86 18202513787; wangyueying9228@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 11, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share