Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling
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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yueying Wang
- 電話番号：+86 18202513787
- メール：wangyueying9228@163.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Systemic Inflammatory Markers (hs-CRP, IL-6, and sST2)
時間枠：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)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major Adverse Cardiovascular Events (MACE)
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-358
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。