Heart plaque showdown: combo pill vs. super statin
NCT ID NCT06767345
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Atherosclerosis of coronary artery are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGSeoul, Seoul, 02841, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart bypass surgeons test which vein layout keeps grafts open
- A soft patch that watches your heart beat in real time
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
- Squeeze a ball, lower your blood pressure? heart trial puts handgrip exercise to the test
- New heart scan aims to spot hidden plaque before it strikes
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?