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Heart plaque showdown: combo pill vs. super statin

NCT ID NCT06767345

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two approaches to stabilize fatty plaque in heart arteries: a moderate-dose statin plus ezetimibe versus a high-dose statin alone. Over 400 adults with coronary artery disease will be followed for a year, using advanced ultrasound to measure plaque changes. The goal is to see if the combination therapy works as well as the stronger statin, potentially offering a safer option.

What this could mean

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

Active substance
Rosuvastatin and ezetimibe
What this could lead to
If successful, this could show that a moderate statin combined with ezetimibe is just as good as a high-dose statin at stabilizing artery plaque, potentially offering a gentler option for heart disease patients.
What could go wrong
This is a Phase 4 trial with 408 participants, so results are still limited. The study focuses on imaging changes, not directly on preventing heart attacks, and the combination therapy might not prove superior or even non-inferior to the standard high-dose statin.

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 408 people

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

Started

May 2025

Expected to finish

Jun 2028

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

18 years and older

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: * Adult men and women over the age of 18 years. * Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging. * At least one major native coronary artery ("target vessel") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure: * Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation. * Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment. * Target vessel is not a bypass graft (aortic or arterial) or a bypassed graft vessel. * Target vessel has not undergone PCI within the target segment. * Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment). * Patients who have provided written informed consent to participate in the study. Exclusion Criteria: * Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation. * History of coronary artery bypass graft surgery (CABG). * Unstable clinical condition (hemodynamic or electrical instability). * Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation. * Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening. * Active liver disease or liver dysfunction. * Severe renal dysfunction (eGFR \<30 mL/min/1.73m²) * Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel. * Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator. * Planned surgery within 12 months. * Currently enrolled in another investigational device or drug study. * Estimated life expectancy of less than 2 years. * Women of childbearing potential (under 50 years of age) who: * Had their last menstrual period within the last 12 months. * Have not had tubal ligation, oophorectomy, or hysterectomy.

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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

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seoul, 02841, South Korea

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