Not recruiting

Study on Rosuvastatin and Atorvastatin for Preventing Heart Disease in Patients with High Genetic Risk

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on preventing heart disease in people who have a high genetic risk for developing it. The study will use medications called statins, which are commonly used to lower cholesterol levels in the blood. The specific statins being studied are rosuvastatin and atorvastatin. These medications work by blocking a substance your body needs to make cholesterol, which can help prevent heart disease.

The purpose of the study is to see if taking statins can reduce the risk of heart-related problems and death in people with a high genetic risk for heart disease. Participants in the study will be randomly assigned to receive either a statin or a placebo. The study will last for about five years, during which time participants will take the medication daily and have regular check-ups to monitor their health and any side effects.

Throughout the study, researchers will look at how well the statins work in preventing major heart problems, such as heart attacks and strokes. They will also monitor other health factors like cholesterol levels, blood pressure, and overall health. The study aims to provide valuable information on whether using statins based on genetic risk can be an effective way to prevent heart disease.

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
Joining the trial
Upon joining the trial, you will be required to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age and confirming your high polygenic risk for coronary artery disease through the Estonian Biobank.
Step 3
Medication administration
You will be assigned to receive either rosuvastatin or atorvastatin, both of which are taken orally. The specific dosage and frequency will be determined by the study team based on your individual needs.
Step 4
Regular follow-ups
Regular follow-up appointments will be scheduled to monitor your health and the effectiveness of the medication. These appointments will include assessments of your cardiovascular health and any side effects you may experience.
Step 5
End of trial
The trial is expected to conclude by February 1, 2030. At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes and any changes in your health status.

Who can join the trial?

5 criteria

Men aged 45-80 on 1st of January 2025
Women aged 55-80 on 1st of January 2025
Have a high polygenic risk for coronary artery disease, which means having a genetic makeup that increases the chance of developing this condition. This must be confirmed by the Estonian Biobank.
The family doctor of the participant must be part of the study.
Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

Patients with a **high polygenic risk** for coronary artery disease cannot participate. This means if your genetic makeup shows a high risk for this heart condition, you are not eligible.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a **vulnerable population** cannot participate. This refers to groups of people who might need special protection or care.

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Verified sites

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Responsive
North Estonia Medical Centre Foundation
Tallin, Estonia
Verified
Tartu University Hospital
Tartu, Estonia

Trial locations

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Investigated drugs

Statin Therapy is a treatment used to lower cholesterol levels in the blood. Cholesterol is a type of fat that can build up in your arteries, making them narrow and hard, which can lead to heart problems. Statins work by blocking a substance your body needs to make cholesterol, which helps to reduce the risk of heart attacks and strokes. In this trial, statin therapy is being used to see if it can help prevent heart disease in people who have a high genetic risk for it.

What is already known about the treatment

Statin Therapy – Statin therapy is administered orally in the form of tablets. It is currently well-established in medical practice and literature as a treatment for lowering cholesterol levels and preventing cardiovascular diseases. The main therapeutic indication for statins in this trial is to prevent cardiovascular events in individuals with a high genetic risk for coronary artery disease. Statins work by blocking a substance your body needs to make cholesterol, which helps reduce the buildup of cholesterol in the arteries. They belong to the pharmacological class of lipid-lowering agents.

Investigated diseases

Coronary Artery Disease – Coronary artery disease is a condition characterized by the narrowing or blockage of the coronary arteries, usually caused by atherosclerosis. Atherosclerosis involves the buildup of cholesterol and fatty deposits (plaques) on the inner walls of the arteries. As the plaques grow, they can restrict blood flow to the heart muscle, leading to chest pain (angina) or heart attacks. The disease progresses as these plaques continue to accumulate, potentially leading to more severe blockages. Over time, reduced blood flow can weaken the heart muscle and contribute to heart failure. The progression of coronary artery disease can vary, with some individuals experiencing rapid development of symptoms, while others may have a slower progression.