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Can a Triple-Drug cholesterol blitz make heart plaques safer?

NCT ID NCT07799779

Disease control Sponsor: Seoul National University Bundang Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether starting a powerful cholesterol-lowering combination right after a heart attack can make the fatty plaques in coronary arteries more stable. Researchers will compare an early intensive strategy using a high-intensity statin, ezetimibe, and inclisiran against the standard stepwise approach. Using imaging called optical coherence tomography, they will measure changes in the plaque's protective cap thickness over 12 months in 294 participants. The goal is to see if the aggressive treatment leads to thicker, more stable plaque caps, which could reduce the risk of future heart events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of high-intensity statin (atorvastatin or rosuvastatin), ezetimibe, and inclisiran, given early after a heart attack to aggressively lower cholesterol.
What this could lead to
If it works, this approach could help prevent future heart attacks by making cholesterol plaques in the arteries more stable and less likely to rupture.
What could go wrong
This is a Phase 4 trial with 294 participants, so results may not apply to everyone. The intensive drug combination may cause side effects like muscle pain or liver issues, and the plaque changes measured may not directly translate to fewer heart attacks.

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 294 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 85 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: 1. Age 19 to 85 years. 2. Hospitalization for acute coronary syndrome (UA, NSTEMI, or STEMI) with planned coronary angiography and PCI, or PCI already performed during the index hospitalization with adequate baseline OCT images obtained during the procedure that meets the study imaging analysis criteria. 3. Presence of a target vessel/segment considered by the investigator to be suitable for OCT assessment at baseline and at the 12-month follow-up. 4. LDL-C level at screening meeting one of the following criteria according to background lipid-lowering therapy: i) ≥40 mg/dL in patients receiving stable combination therapy with a statin and ezetimibe, defined as no dose change for at least 4 weeks before screening; ii) ≥55 mg/dL in patients receiving high-intensity statin therapy; iii) ≥70 mg/dL in patients receiving low- or moderate-intensity statin therapy; or iv) ≥100 mg/dL in patients not receiving stable statin therapy. 5. Provision of voluntary written informed consent after receiving sufficient information regarding the study objectives, procedures, and follow-up plan. Exclusion Criteria: 1. Severe hepatic dysfunction, defined as AST or ALT \>3 times the upper limit of normal. 2. CK \>5 times the upper limit of normal or suspected clinically significant myopathy. 3. Severe renal impairment, defined as eGFR \<30 mL/min/1.73 m². 4. Severe hypersensitivity to or contraindication to statins, ezetimibe, or inclisiran. 5. Pregnancy, breastfeeding, or plans to become pregnant during the study period. 6. Inability to undergo 12-month follow-up coronary angiography and OCT. 7. Life expectancy \<1 year or, in the investigator's judgment, inappropriate participation in the study because of concerns regarding adherence or safety.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Plaque, Atherosclerotic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndromes (ACS)

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

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

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