An observational study in Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome and Coronary Artery Disease, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Ruijin Hospital · Observational
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 420 is below the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 18 years and older, of any sex.
Exclusion Criteria:
Women who are planning a pregnancy, currently pregnant, or lactating.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
atients with acute or chronic coronary syndrome who are prescribed Icosapent ethyl (IPE) in addition to their standard of care (including statin therapy).
Patients with acute or chronic coronary syndrome receiving standard of care (including statin therapy) only, without Icosapent ethyl.
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).
Time frame: 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).
Time frame: 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) \[Lp(a)\].
Time frame: Baseline, 1 month, 6 months, and 12 months
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.
Time frame: Baseline, 1 month, 6 months, and 12 months
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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month, 6 months, and 12 months
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.
Time frame: Up to 12 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Up to 12 months
No study locations are listed for this record.
Plan to share: No — 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.
Start is estimated for May 2026; primary completion for May 2028, 24 months later.
Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 24 months is below that.
Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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