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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

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
Tartu University Hospital Tartu Estonia
North Estonia Medical Centre Foundation Tallin Estonia

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

Trial status

Country Status Recruitment Start
Estonia Estonia
Not recruiting
01.02.2025

Trial locations

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.

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.

Trial ID:
2024-513424-42-01
Protocol code:
EEPRS12308
NCT ID:
NCT06820086
Trial Phase:
Therapeutic confirmatory (Phase III)

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