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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Echocardiographic Parameters of Ventricular Remodeling | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 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) |
Inclusion Criteria:
Age 18 years and older, of any sex.
Exclusion Criteria:
Women who are planning a pregnancy, currently pregnant, or lactating.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueying Wang | Contact | +86 18202513787 | wangyueying9228@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30415628 | Result | 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. |
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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.
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| D020257 | Ventricular Remodeling |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Evaluate changes in Hemoglobin A1c (HbA1c) among participants with a history of diabetes. | Baseline, 1 month, 6 months, and 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 |
| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |