Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

8. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

420

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
Zeitfenster: 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
Change from Baseline in Vulnerable Plaque Markers (Lp-PLA2 and UACR)
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Adverse Cardiovascular Events (MACE)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ruijin Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Mai 2026

Primärer Abschluss (Geschätzt)

30. Mai 2028

Studienabschluss (Geschätzt)

30. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-358

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Koronare Herzkrankheit

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Mauritius

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren