Not yet recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

7 criteria

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 trial?

14 criteria

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

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Semmelweis University
Responsive
Budapest, Hungary

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

Rosuvastatin

What is already known about the treatment

Statin medications – A class of cholesterol-lowering drugs taken orally in tablet form that work by blocking an enzyme needed for cholesterol production in the liver. These medications are widely used and well-documented in medical literature as a primary treatment for coronary artery disease and high cholesterol levels. Statins reduce the risk of heart attacks and strokes by decreasing the formation of plaques in blood vessels through their ability to lower LDL (bad) cholesterol and slightly raise HDL (good) cholesterol levels. They belong to the lipid-lowering agent pharmacological class and are considered a cornerstone therapy in cardiovascular disease prevention, with extensive clinical evidence supporting their safety and effectiveness when used as prescribed. Note: Since the specific statin medication is not named in the source data, I provided a general description of the statin drug class. Common examples include atorvastatin, simvastatin, and rosuvastatin, but the trial data doesn't specify which one was used.

Investigated diseases

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.