Could a purified fish oil calm the 'hot' plaques that trigger heart attacks?
NCT ID NCT07762755
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether icosapent ethyl, a purified form of fish oil, can stabilize high-risk coronary plaques in people with heart disease. Participants have plaques that narrow a major heart artery by 30–70% and show at least one high-risk feature on a CT scan. Half will take icosapent ethyl (2 g twice daily) plus their usual cholesterol-lowering therapy for 12 months; the other half will continue their usual therapy alone. Using a special PET/CT scan that highlights inflamed plaques, the study will measure whether the drug reduces plaque activity and improves plaque stability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Icosapent ethyl (a purified fish-oil derivative) taken as 2 g twice daily for 12 months, added to standard cholesterol-lowering therapy.
- What this could lead to
- If it works, this could point toward a way to stabilize dangerous coronary plaques and reduce heart attack risk in people already on cholesterol-lowering drugs.
- What could go wrong
- This is a mid-stage trial with 100 participants, so results may not apply broadly. The drug can cause side effects like joint pain or an increased risk of atrial fibrillation, and the imaging changes may not translate into fewer heart events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
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