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New CT scans reveal Statins' secret effect on heart plaque

NCT ID NCT06603363

Knowledge-focused Sponsor: Prof. Maurovich-Horvat Pál Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a short course of high-dose statins affects fatty buildup (plaque) in the heart arteries of people with mild heart disease. Researchers will use advanced CT scans to measure changes in plaque size and type over 3 months, and then check if those changes last after stopping the drug. The goal is to understand who benefits most from statins and why.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

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

Started

May 2025

Expected to finish

Dec 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

45 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: * patients referred for coronary computed tomography angiography (CTA) * females aged 45-75 years and males aged 40-75 years * presence of at least mild coronary atherosclerosis (luminal stenosis \>25%, with at least one partially calcified or non-calcified plaque) * statin-naive patients * ability to understand and provide written informed consent * FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis Exclusion Criteria: * contraindications to coronary CTA * current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe) * age below 45 years in females or below 40 years in males * age above 75 years in both sexes * pregnancy or breastfeeding * type 1 or type 2 diabetes mellitus * history of coronary stent implantation or coronary artery bypass grafting * history of myocardial infarction * ≥70% luminal stenosis in the proximal left anterior descending artery (LAD), or ≥50% stenosis in the left main (LM) coronary artery * FFR-CT value \<0.75 in any coronary artery * elevated serum alanine aminotransferase (ALT) levels (\>3× the upper limit of normal) * elevated serum creatine kinase (CK) levels (\>3× the upper limit of normal) * LDL cholesterol level \>5 mmol/L * renal failure or significantly impaired renal function (eGFR \<30 mL/min/1.73 m²) * ongoing oncological treatment * active liver disease * known hypersensitivity to any excipients of the investigational product * concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir * concomitant treatment with cyclosporine * women of childbearing potential not using adequate contraception * presence of myopathy

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Conditions

The condition(s) this trial relates to.

arteriosclerosis disorder cardiovascular disorder coronary artery disorder coronary atherosclerosis heart disorder hyperlipidemia Plaque, Atherosclerotic vascular disorder

As listed by the trial registrant

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

Arteriosclerosis Atherosclerotic plaque Cardiovascular diseases Coronary artery disease Coronary computed tomography angiography Heart diseases Hyperlipidemia Multidetector computed tomography Statin therapy Vascular diseases

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

  • Semmelweis University, Medical Imaging Centre

    RECRUITING

    Budapest, Budapest, 1082, Hungary

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