Study of Rosuvastatin Effects on Coronary Artery Plaque Volume in Patients with Stable Chest Pain Using CT Imaging

4 1 1

What is this study about?

This study focuses on patients with Coronary Artery Disease who experience stable chest pain. The research examines how statin therapy affects the characteristics of coronary artery plaques, which are deposits that can build up in blood vessels of the heart. The study uses Coronary Computed Tomography Angiography, a specialized imaging technique that creates detailed pictures of heart blood vessels.

The treatment involves comparing two medications: Xeter (which contains rosuvastatin, a type of statin medication that helps lower cholesterol) and placebo. The study aims to measure changes in the volume and composition of plaques in heart arteries after three months of treatment.

During the study, participants will undergo heart imaging at the beginning of the study and after three months of taking either Xeter or placebo. The medication is taken as a film-coated tablet by mouth. The maximum daily dose of Xeter is 40 milligrams, and treatment continues for up to 12 months. The study will track various aspects of heart health and monitor how the plaques in the arteries may change over time.

1 Initial CT scan

You will undergo a coronary CT scan (detailed X-ray images of heart arteries)

The scan will check for presence of plaques (deposits in heart arteries) and their characteristics

2 Medication start

You will receive either Xeter 10 mg tablets (containing rosuvastatin) or placebo tablets

The medication should be taken by mouth once daily

This treatment will continue for 3 months

3 3-month follow-up

After 3 months, you will have another coronary CT scan

Blood tests will be performed to check various parameters including cholesterol levels

Your doctor will assess any potential side effects

4 Long-term follow-up

The final follow-up visit will occur at 24 months

A third coronary CT scan will be performed

Final blood tests and health assessment will be conducted

The study will monitor for any health events throughout the entire period

5 Health monitoring

Throughout the study, you will be monitored for any health changes

Regular checks will include assessment for common side effects such as muscle pain, digestive issues, or skin reactions

Any serious health events will be recorded and addressed

Who Can Join the Study?

  • You must be between 45-75 years old if you are female, or 40-75 years old if you are male
  • You must have a medical need for a coronary CT angiography (a specialized X-ray test that looks at blood vessels in your heart)
  • You must not have taken statins before (medications that lower cholesterol)
  • You must not have any conditions that would prevent you from having a CT angiography scan
  • You must have at least one partially-calcified or non-calcified plaque (buildup in your heart arteries that isn’t completely hardened)
  • Your FFRCT value must be greater than 0.75 below the narrowing in your artery (FFRCT is a measurement that shows how much a blockage affects blood flow to your heart)
  • You must be able to understand and sign the informed consent form for the study

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Known allergy or intolerance to statins (cholesterol-lowering medications)
  • Previous heart attack or unstable heart conditions
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Inability to undergo Coronary CT Angiography (special X-ray examination of heart arteries)
  • Severe kidney disease that prevents the use of contrast dye for imaging
  • History of severe allergic reactions to contrast agents used in imaging
  • Uncontrolled high blood pressure
  • Active liver disease or abnormal liver function tests
  • Recent major surgery (within last 3 months)
  • Any condition that, in the opinion of the study doctor, makes participation unsafe
  • Unable to provide informed consent
  • History of irregular heart rhythm that could affect imaging quality

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Semmelweis University Budapest Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not yet recruiting
01.07.2025

Trial locations

Investigated drugs:

Statin is a type of medication that helps lower cholesterol levels in the blood. It works by reducing the amount of cholesterol your body produces, particularly in the liver. This medication helps prevent the build-up of fatty deposits (plaques) in blood vessels, which can lead to heart disease and other cardiovascular problems. Statins are commonly prescribed to help reduce the risk of heart attacks and strokes by making blood vessels healthier and improving blood flow.

Coronary Artery Disease – A condition where the major blood vessels that supply the heart become damaged or diseased. It develops when fatty deposits, cholesterol, and other substances build up in the walls of coronary arteries. This buildup, called plaque, causes the arteries to narrow over time. As the arteries narrow, blood flow to the heart becomes restricted. The reduced blood flow can cause chest pain (angina), shortness of breath, or other symptoms. The disease typically develops over decades, and its progression can be influenced by various risk factors.

Stable Chest Pain – A predictable pattern of chest discomfort that typically occurs with physical activity or emotional stress. The pain or discomfort, also known as stable angina, is caused by reduced blood flow to the heart muscle. It usually feels like pressure or tightness in the chest, and may also be felt in the shoulders, arms, neck, jaw, or back. The symptoms typically last a few minutes and improve with rest. Unlike unstable angina, the pattern and intensity of pain remain consistent over time.

Trial ID:
2025-522868-32-00
Protocol code:
INTENSE
NCT ID:
NCT06603363
Trial Phase:
Therapeutic use (Phase IV)

Other Trials to Consider

  • Comparison of Obicetrapib and Bempedoic Acid in Patients with Dyslipidemia at High to Very High Cardiovascular Risk

    Recruiting

    3 1 1
    Investigated diseases:
    Czechia Germany Italy The Netherlands Poland Slovakia +1
  • Study of dapagliflozin and semaglutide to reverse prediabetes to normal blood sugar levels in patients with coronary artery disease

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark