Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
8 juni 2026 bijgewerkt door: Ruijin Hospital
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
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Observationeel
Inschrijving (Geschat)
420
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Yueying Wang
- Telefoonnummer: +86 18202513787
- E-mail: wangyueying9228@163.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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).
|
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Control Cohort
Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Tijdsspanne: 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).
|
Baseline, 1 month, 6 months, and 12 months
|
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Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Tijdsspanne: 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).
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from Baseline in Lipid Profile Parameters
Tijdsspanne: 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)].
|
Baseline, 1 month, 6 months, and 12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Tijdsspanne: 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.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
|
Evaluate changes in the myocardial wall stress and heart failure biomarker NT-proBNP.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Tijdsspanne: Baseline and 9 or 12 months
|
Change in Coronary Plaque Maximum Thickness Evaluated by CTA (Unit: mm)
|
Baseline and 9 or 12 months
|
|
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Tijdsspanne: Baseline and 9/12 months
|
Change in Coronary Plaque Length Evaluated by CTA (Unit: mm)
|
Baseline and 9/12 months
|
|
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Tijdsspanne: Baseline and 9/12 months
|
Change in Coronary Plaque Area Evaluated by CTA (Unit: mm^2)
|
Baseline and 9/12 months
|
|
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Tijdsspanne: Baseline and 9/12 months
|
Change in Degree of Coronary Luminal Stenosis Evaluated by CTA (Unit: percentage)
|
Baseline and 9/12 months
|
|
Change in Coronary Plaque Morphology and Stenosis Evaluated by Coronary CTA
Tijdsspanne: Baseline and 9/12 months
|
Change in Proportion of Hypoechoic Plaque Components Evaluated by CTA (Unit: percentage)
|
Baseline and 9/12 months
|
|
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
|
Evaluate changes in Fasting Blood Glucose (FBG) among participants with a history of diabetes.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
|
Evaluate changes in Insulin (INS) among participants with a history of diabetes.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Tijdsspanne: 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.
|
Baseline, 1 month, 6 months, and 12 months
|
|
Change from Baseline in Glucose Metabolism Parameters in the Diabetic Subpopulation
Tijdsspanne: Baseline, 1 month, 6 months, and 12 months
|
Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes.
|
Baseline, 1 month, 6 months, and 12 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Major Adverse Cardiovascular Events (MACE)
Tijdsspanne: 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.
|
Up to 12 months
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tijdsspanne: 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.
|
Up to 12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 mei 2026
Primaire voltooiing (Geschat)
30 mei 2028
Studie voltooiing (Geschat)
30 mei 2029
Studieregistratiedata
Eerst ingediend
25 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2026
Eerst geplaatst (Werkelijk)
11 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
8 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Vaatziekten
- Hart-en vaatziekten
- Pathologische processen
- Pathologische aandoeningen, anatomisch
- Hartziekten
- Arteriosclerose
- Arteriële occlusieve ziekten
- Hart-en vaatziekte
- Myocardiale ischemie
- Pathologische aandoeningen, tekenen en symptomen
- Ontsteking
- Coronaire hartziekte
- Acute kransslagader syndroom
- Ventriculaire remodellering
Andere studie-ID-nummers
- 2026-358
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
De-identified individual participant data (IPD) that underlie the results reported in the primary publication, along with the study protocol and statistical analysis plan, will be shared.
Data will be available upon reasonable request to the Principal Investigator, beginning 6 months and ending 36 months following article publication.
To gain access, researchers must submit a methodologically sound proposal for secondary analysis or meta-analysis. The proposal will be reviewed by the study steering committee. If approved, data sharing will be strictly subject to a formal data-sharing agreement and must comply with the ethical regulations of the participating institutions. No specific IPD will be shared unconditionally.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .