A Phase 4 interventional study of icosapent ethyl (IPE) and Standard LDL-C-Lowering Therapy in Coronary Artery Disease, Hyperlipidaemia and Hypertriglyceridaemia, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by China National Center for Cardiovascular Diseases · Phase 4, Interventional, and Treatment
This randomized controlled study will evaluate whether icosapent ethyl (IPE) can improve and stabilize high-risk coronary plaques in patients receiving stable low-density lipoprotein cholesterol (LDL-C)-lowering therapy. Potential participants will have coronary plaques identified by coronary computed tomography angiography (CCTA), with 30% to 70% narrowing in at least one major coronary artery and at least one high-risk plaque feature.
After baseline imaging with fluorine-18 sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT), eligible participants will be randomly assigned in a 1:1 ratio to receive either IPE 2 g twice daily plus standard LDL-C-lowering therapy or standard LDL-C-lowering therapy alone for 12 months. At the end of treatment, participants will undergo repeat CCTA and 18F-NaF PET/CT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.
This study consists of three main stages. First, a screening cohort will be established using CCTA. Individuals with 30% to 70% diameter narrowing in at least one major coronary artery-the left anterior descending, left circumflex, or right coronary artery-and at least one high-risk plaque feature will be considered for further screening. High-risk plaque features assessed by experienced imaging specialists include increased pericoronary fat attenuation, low-attenuation plaque, positive remodeling, spotty calcification, and the napkin-ring sign. This screening process is intended to identify appropriate and reliably characterized candidates for the randomized study.
Eligible participants will undergo baseline 18F-NaF PET/CT imaging and then be randomly assigned in a 1:1 ratio using a centralized block randomization system. Participants in the intervention group will receive IPE 2 g twice daily for 12 months in addition to stable LDL-C-lowering therapy. Participants in the control group will continue stable LDL-C-lowering therapy without IPE. The LDL-C-lowering regimen should be stable for more than 4 weeks before randomization.
After 12 months, participants in both groups will undergo follow-up CCTA and 18F-NaF PET/CT to evaluate changes in coronary plaque characteristics and disease activity. Follow-up will also include measurements of relevant plasma biomarkers and monitoring for major adverse cardiovascular events. Imaging data will be acquired using standardized procedures and interpreted by experienced imaging specialists.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 100 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral icosapent ethyl 2 g twice daily for 12 months in addition to their stable LDL-C-lowering therapy. CCTA and 18F-NaF PET/CT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.
Drug: icosapent ethyl (IPE) · Drug: Standard LDL-C-Lowering Therapy
Participants will continue their stable LDL-C-lowering therapy for 12 months without receiving icosapent ethyl. CCTA and 18F-NaF PET/CT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.
Drug: Standard LDL-C-Lowering Therapy
Icosapent ethyl will be administered orally at a dose of 2 g twice daily (total daily dose of 4 g) for 12 months, in addition to stable LDL-C-lowering therapy.
Also known as: IPE, Ethyl Eicosapentaenoate, Eicosapentaenoic Acid Ethyl Ester
Participants will continue an individualized, stable LDL-C-lowering regimen throughout the 12-month study period. The LDL-C-lowering regimen must have remained stable for more than 4 weeks before randomization. This background therapy will be administered in both study arms.
Absolute Change From Baseline in Maximum Target-to-Background Ratio of the Target Coronary Lesion
The target lesion is defined as the coronary lesion with the highest maximum target-to-background ratio (TBRmax) at baseline. TBRmax is calculated as the maximum standardized uptake value (SUVmax) of the target lesion divided by the mean standardized uptake value (SUVmean) of the blood-pool background measured in the right atrium, superior vena cava, or inferior vena cava. Absolute change is calculated as the Month 12 TBRmax minus the baseline TBRmax.
Time frame: Baseline and Month 12
Percentage Change From Baseline in TBRmax of the Target Coronary Lesion
The target lesion is the coronary lesion with the highest TBRmax at baseline. Percentage change is calculated as \[(Month 12 TBRmax - baseline TBRmax) / baseline TBRmax\] × 100%.
Time frame: Baseline and Month 12
Change From Baseline in SUVmax of the Target Coronary Lesion
Change in the maximum standardized uptake value of the prespecified target coronary lesion, calculated as the Month 12 value minus the baseline value.
Time frame: Baseline and Month 12
Change From Baseline in Total Volume of 18F-NaF-Positive Coronary Plaque
Total volume of coronary plaque demonstrating positive 18F-NaF uptake, defined as TBRmax greater than 1.25. Change is calculated as the Month 12 volume minus the baseline volume.
Time frame: Baseline and Month 12
Change From Baseline in the Number of 18F-NaF-Positive Coronary Segments
Number of coronary artery segments with positive 18F-NaF uptake, defined as TBRmax greater than 1.25. Change is calculated as the Month 12 count minus the baseline count.
Time frame: Baseline and Month 12
Change From Baseline in Pericoronary Fat Attenuation Index at the Target Plaque
Pericoronary fat attenuation index (FAI), measured in Hounsfield units using CCTA at the location of the target plaque. Change is calculated as the Month 12 value minus the baseline value.
Time frame: Baseline and Month 12
Change From Baseline in Percent Atheroma Volume at the Target Plaque
Percent atheroma volume (PAV) will be measured using CCTA. Change is calculated as the Month 12 value minus the baseline value.
Time frame: Baseline and Month 12
Change From Baseline in CCTA-Derived Coronary Plaque Component Volumes
CCTA will be used to measure changes in total plaque, noncalcified plaque, calcified plaque, and low-attenuation noncalcified plaque volumes. For each component, change is calculated as the Month 12 volume minus the baseline volume.
Time frame: Baseline and Month 12
Change in Plasma triglycerides Levels From Baseline to Month 12
Plasma levels of triglycerides (TG) will be measured.
Time frame: Baseline and Month 12
Percentage Change From Baseline in Plasma High-Sensitivity C-Reactive Protein Level
Percentage change will be calculated as \[(Month 12 hs-CRP - baseline hs-CRP) / baseline hs-CRP\] × 100%.
Time frame: Baseline and Month 12
Change in Plasma Eicosapentaenoic Acid Level From Baseline to Month 12
Plasma eicosapentaenoic acid (EPA) concentration will be measured and reported in its applicable concentration unit (e.g., μg/mL or % of total fatty acids, according to the laboratory assay).
Time frame: Baseline and Month 12
Exploratory Incidence of Three-Point Major Adverse Cardiovascular Events
Number and percentage of participants experiencing a three-point major adverse cardiovascular event (3P-MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or nonfatal stroke.
Time frame: From randomization through Month 12
Exploratory Incidence of Four-Point Major Adverse Cardiovascular Events
Number and percentage of participants experiencing a four-point major adverse cardiovascular event (4P-MACE), defined as 3P-MACE plus ischemia-driven coronary revascularization.
Time frame: From randomization through Month 12
Plan to share: No — Individual participant data will not be shared because of participant privacy and confidentiality considerations and applicable institutional ethics and data governance requirements. Deidentified aggregate study results may be reported in scientific publications and presentations.
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Studies of the drug tested here: Eicosapentaenoic acid ethyl ester
China National Center for Cardiovascular Diseases →