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Could a purified fish oil calm the 'hot' plaques that trigger heart attacks?

NCT ID NCT07762755

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037, China

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