AuthorisedPhase II and Phase III (Integrated)Interventional

Changes in plaque characteristics after short-term statin therapy assessed with coronary CT

This research is investigating how a short period of taking statin medication affects the fatty deposits, called plaque, that can build up in the heart's arteries. These plaques are linked to coronary artery disease. Scientists are using a special type of CT scan, called a Coronary CT, to carefully measure changes in the amount and type of plaque after three months of treatment. The study also tracks what happens to the plaque over a longer period, up to 24 months, and looks at overall heart health and any side effects from the medication. It's a combined Phase II and Phase III study, which means it's looking closely at both the effectiveness and safety of this approach.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Semmelweis University

Enrolment target

140

Start

26 Sep 2025

Coronary Artery Disease Cardiology Statin Therapy Coronary Computed Tomography Angiography Stable chest pain

What is this study about?

This clinical trial is designed to understand how a common medication called a statin might help reduce or change the fatty build-up in your heart arteries. This build-up, known as plaque, can narrow your arteries and lead to a heart condition called coronary artery disease. Statins are often prescribed to lower cholesterol, and this study wants to see if they can also directly affect these plaques after just a short time.

Researchers will use a special imaging test called a Coronary CT angiogram. This is like an advanced X-ray that creates very detailed pictures of your heart and its blood vessels. They will use this scan to carefully measure the amount of plaque in your arteries, particularly the 'non-calcified' type, which is often considered more prone to causing problems. They will do this at the start of the study and then again after three months of taking the statin medication.

The main goal is to see if the amount of non-calcified plaque has changed after three months. They will also keep an eye on plaque changes over 24 months, check for any serious or minor side effects, and measure various things in your blood like cholesterol levels. This research is important because it could help doctors understand more about how statins work on plaques and whether a short course of treatment can make a significant difference to heart health.

Key takeaways

This study investigates how statins affect fatty plaque in heart arteries.
It uses special heart scans (Coronary CT) to measure plaque changes.
The main focus is on changes in plaque after 3 months of statin therapy.
The study also tracks long-term effects and potential side effects.
Participants will receive either a statin or a placebo tablet.

Who may be eligible?

This study is looking for adults aged 18 or older. Both men and women can take part.

To be considered for this study, you would need to have been diagnosed with coronary artery disease and be experiencing stable chest pain. The study specifically wants to see how statin therapy affects your heart.

There might be other specific health requirements or conditions that would make someone unsuitable for the study, which would be discussed in detail by the study team.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of coronary artery disease?
Are you currently experiencing stable chest pain?
Are you comfortable potentially taking either a statin or a placebo?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would start by having a detailed health check-up, including blood tests and a special heart scan called a Coronary CT angiogram. You would then be given either a statin tablet (called Xeter 10 mg) or a placebo tablet, which looks identical but contains no active medicine. This helps researchers compare the effects accurately.

You would take this medication daily for a period of three months. During this time, and at the three-month mark, you would have follow-up visits. These visits would include more blood tests, checks for any side effects (like muscle pain or headaches), and another Coronary CT angiogram to see how the plaque in your arteries has changed.

The study also includes longer-term follow-up visits, which might involve further scans and checks up to 24 months after you start the medication, to see the lasting effects.

Potential risks and benefits

Taking part in this study might offer a potential benefit of closely monitoring your heart health with advanced scans and receiving a statin medication that could help manage your coronary artery disease. However, as with any medication, there are potential risks and side effects from statins, which can include muscle pain, digestive issues, or headaches, though many people tolerate them well. There's also a chance you could receive a placebo, meaning you wouldn't get the active drug in the short term. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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Hungary

Common questions

What is 'plaque' in my arteries?

Plaque is a build-up of fatty substances and cholesterol in your arteries, which can make them narrower and harder for blood to flow through.

What is a statin?

Statins are medicines commonly prescribed to help lower cholesterol levels in your blood.

What is a Coronary CT scan?

It's a special X-ray scan that takes detailed pictures of your heart and the arteries supplying it, allowing doctors to see problems like plaque build-up.

What is a 'placebo'?

A placebo is a tablet that looks exactly like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the actual drug.

How long will I be in this study?

You will take medication for about three months, with follow-up appointments and scans continuing for up to 24 months.