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Coronary Artery DiseasePhase 4IPE-NaFNCT07762755

Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT

A Phase 4 study testing icosapent ethyl (IPE) and Standard LDL-C-Lowering Therapy in people with Coronary Artery Disease and Hyperlipidaemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
icosapent ethyl (IPE) and Standard LDL-C-Lowering Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Aug 2026to 31 Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants aged 18 to 75 years.
  • Ability to understand the study and provide written informed consent before enrollment.
  • Receiving a stable lipid-lowering regimen before enrollment, with the type and dose of statin therapy remaining unchanged for at least 4 weeks.
  • Fasting triglyceride level below 5.6 mmol/L.
  • Presence of at least one of the following high-risk plaque features on coronary computed tomography angiography (CCTA):Pericoronary fat attenuation index greater than -70.1 Hounsfield units;
  • Low-attenuation plaque below 30 Hounsfield units;
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  • Positive remodeling index greater than 1.1;
  • Spotty calcification;
  • or Napkin-ring sign, defined as a low-attenuation plaque core surrounded by a rim of higher attenuation.

Who cannot join

  • Current participation in another investigational drug, device, or procedure study, or receipt of an investigational drug or device within 4 weeks before enrollment.
  • Treatment with icosapent ethyl within 12 months before enrollment.
  • Known intolerance or hypersensitivity to icosapent ethyl or fish oil.
  • A previous diagnosis of homozygous familial hypercholesterolemia or hyperlipidemia requiring hemodialysis.
  • Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, or stroke within 3 months before enrollment;
  • Planned cardiac surgery, percutaneous coronary intervention, or carotid artery stenting, or planned major noncardiac surgery during the study.
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  • A known contraindication or limitation to PET/CT, including exceeding scanner weight limits or having a device, carotid or aortic stent, or vascular graft that may cause imaging artifacts.
  • Autoimmune disease, vasculitis, or active inflammatory disease.
  • Serious infection within 1 month before enrollment or a current infection requiring intravenous antibiotic treatment.
  • Use within 6 weeks before enrollment or current use of medications that may significantly affect plaque inflammation, including oral, rectal, or injectable corticosteroids or immunosuppressive agents, such as cyclosporine, methotrexate, tacrolimus, azathioprine, antithymocyte globulin, sirolimus, anti-tumor necrosis factor agents such as infliximab, anti-interleukin-6 therapy such as tocilizumab, or anti-interleukin-1 therapy.
  • Use within 6 weeks before enrollment or current use of aspirin at a dose greater than 325 mg/day or nonsteroidal anti-inflammatory drugs at a dose greater than 1,000 mg/day.
  • Treatment within 12 months before enrollment with a cholesteryl ester transfer protein inhibitor, including anacetrapib, dalcetrapib, or evacetrapib, or with mipomersen or lomitapide.
  • Known clinically significant systemic disease, including hepatic, renal, hematologic, or malignant disease, or any other clinically significant comorbidity that may interfere with study participation or study assessments.
  • History of malignancy within the previous 5 years, except nonmelanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or stage I prostate cancer.
  • Inability or anticipated inability to complete all protocol-required visits or procedures, or any condition that may make the participant unreliable for study participation, including alcohol or other substance abuse within the previous year or a psychiatric disorder.
  • Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during study treatment or within 15 weeks after the last dose of study treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Naqiong Wu, Doctor contact

+86 13501139869

fuwainaqiongwu@163.com

Zheng Yin, Master contact

+8615359270767

yinzheng@fuwai.com

China1 site

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

    Jianing Zhang, Master, +86 (010) 88398662, Zhangjianing@fuwai.com

    Naqiong Wu, Doctor

Other trials in China

About this study

Official title: A Randomized Controlled Trial Evaluating the Effect of Icosapent Ethyl on High-Risk Coronary Plaques Using 18F-Sodium Fluoride PET/CT

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.

Read the detailed description

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.

Being tested
icosapent ethyl (IPE), Standard LDL-C-Lowering Therapy
Keywords
Icosapent Ethyl, IPE, High-Risk Coronary Plaque, Coronary Plaque Stabilization, Coronary Atherosclerosis, Intermediate Coronary Stenosis, 18F-Sodium Fluoride PET/CT, 18F-NaF PET/CT, Coronary Computed Tomography Angiography, CCTA, Coronary Microcalcification, Pericoronary Fat Attenuation Index
Medical subject headings
Coronary Artery Disease, Hyperlipidemias, Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • icosapent ethyl (IPE)Drug

    Also called IPE, Ethyl Eicosapentaenoate, Eicosapentaenoic Acid Ethyl Ester

    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.

  • Standard LDL-C-Lowering TherapyDrug

    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.

Study groups in NCT07762755
Study groupRoleWhat they receive
Icosapent Ethyl Plus Standard LDL-C-Lowering TherapyExperimentalParticipants 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.
Receives: Drug: icosapent ethyl (IPE); Drug: Standard LDL-C-Lowering Therapy
Standard LDL-C-Lowering Therapy AloneActive comparatorParticipants 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.
Receives: Drug: Standard LDL-C-Lowering Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Month 12

Secondary outcomes (7)

  1. 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%.

    Measured: Baseline and Month 12

  2. 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.

    Measured: Baseline and Month 12

  3. 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.

    Measured: Baseline and Month 12

  4. 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.

    Measured: Baseline and Month 12

  5. 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.

    Measured: Baseline and Month 12

  6. 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.

    Measured: Baseline and Month 12

  7. 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.

    Measured: Baseline and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible participants will be randomized in a 1:1 ratio to two parallel groups. Both groups will continue stable LDL-C-lowering therapy. The intervention group will additionally receive icosapent ethyl 2 g twice daily for 12 months, while the control group will receive no icosapent ethyl. Participants in both groups will undergo the same baseline and 12-month imaging and follow-up assessments.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07762755
Sponsor's protocol ID
2026-3220
Acronym
IPE-NaF
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Moss A, Daghem M, Tzolos E, Meah MN, Wang KL, Bularga A, Adamson PD, Kwiecinski J, Fletcher A, Dawson D, Arumugam P, Sabharwal N, Greenwood JP, Townend JN, Calvert PA, Rudd JHF, Berman D, Verjans J, Slomka P, Dey D, Forsyth L, Murdoch L, Lee RJ, Lewis S, Mills NL, van Beek EJR, Williams MC, Dweck MR, Newby DE; PREFFIR Investigators. Coronary Atherosclerotic Plaque Activity and Future Coronary Events. JAMA Cardiol. 2023 Aug 1;8(8):755-764. doi: 10.1001/jamacardio.2023.1729.

    PubMed 37379010

  • Sayah N, Bhatt DL, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Jiao L, Pineda AL, Doyle RT Jr, Tardif JC, Ballantyne CM, Steg PG. Icosapent ethyl following acute coronary syndrome: the REDUCE-IT trial. Eur Heart J. 2024 Apr 1;45(13):1173-1176. doi: 10.1093/eurheartj/ehad889. No abstract available.

    PubMed 38252107

  • Budoff MJ, Bhatt DL, Kinninger A, Lakshmanan S, Muhlestein JB, Le VT, May HT, Shaikh K, Shekar C, Roy SK, Tayek J, Nelson JR. Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: final results of the EVAPORATE trial. Eur Heart J. 2020 Oct 21;41(40):3925-3932. doi: 10.1093/eurheartj/ehaa652.

    PubMed 32860032

  • Yang S, Hoshino M, Koo BK, Yonetsu T, Zhang J, Hwang D, Shin ES, Doh JH, Nam CW, Wang J, Chen S, Tanaka N, Matsuo H, Kubo T, Chang HJ, Kakuta T, Narula J. Relationship of Plaque Features at Coronary CT to Coronary Hemodynamics and Cardiovascular Events. Radiology. 2022 Dec;305(3):578-587. doi: 10.1148/radiol.213271. Epub 2022 Aug 16.

    PubMed 35972355

  • Gallone G, Bellettini M, Gatti M, Tore D, Bruno F, Scudeler L, Cusenza V, Lanfranchi A, Angelini A, de Filippo O, Iannaccone M, Baldetti L, Audisio K, Demetres M, Risi G, Rizzello G, Porto I, Fonio P, Prati F, Williams MC, Koo BK, Pontone G, Depaoli A, Libby P, Stone GW, Narula J, de Ferrari GM, d'Ascenzo F. Coronary Plaque Characteristics Associated With Major Adverse Cardiovascular Events in Atherosclerotic Patients and Lesions: A Systematic Review and Meta-Analysis. JACC Cardiovasc Imaging. 2023 Dec;16(12):1584-1604. doi: 10.1016/j.jcmg.2023.08.006. Epub 2023 Oct 4.

    PubMed 37804276

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing icosapent ethyl (IPE) and Standard LDL-C-Lowering Therapy in people with Coronary Artery Disease and Hyperlipidaemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Naqiong Wu, Doctor (+86 13501139869, fuwainaqiongwu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change From Baseline in Maximum Target-to-Background Ratio of the Target Coronary Lesion (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07762755, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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