Active — Not RecruitingPhase 4

Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

Estonia2,714 participantsStarted 2025-03-26

Plain-language summary

This research investigates the potential advantages of intensive preventive statin treatment for healthy men aged 45-80 and women aged 55-80 who possess a high genetic predisposition to coronary artery disease (CAD). By specifically targeting the top 20% of individuals with elevated CAD polygenic risk scores (PRS), the study seeks to find out whether this tailored approach can notably decrease the occurrence of cardiovascular disease and mortality over a five-year period when compared with usual care. Despite the potential of PRS in pinpointing individuals at heightened risk for cardiovascular disease, there is a lack of focused and prospective investigations in existing research. This study aims to bridge this gap by examining whether preventive statin therapy for individuals with high CAD PRS is not only effective in diminishing cardiovascular events but also economically viable. The comparison between the statin treatment arm and standard care practice is conducted in a pragmatic manner at the primary care level.

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men aged 45-80 on 1 January 2025 * Women aged 55-80 on 1 January 2025 * CAD PRS top 20% confirmed by the Estonian Biobank (we intend to sample top 15% PRS individuals but we might have to also include 15-20% PRS individuals to fulfil the required sample size) * The family physician of the study participant has been contracted to participate in the trial * Written informed consent has been provided to participate in the trial Exclusion Criteria: * Diagnosed with ischemic heart disease (I20-I25), stroke or transient ischemia (I60-64, I69, G45), peripheral vascular occlusion (I65-66, I67.2, I70, I73.9), diseases of liver (K70-K77), end stage renal disease (N18.0), mental and behavioural disorders due to psychoactive substance use (F10-F19). \-- The diagnosis must be present at least 2 times on a health claim or prescription within at least a 6-month period between 1.01.2022-31.12.2024. * Currently using statin treatment: * The individual has at least 1 prescription from ATC groups C10AA or C10BA between 01.01.2022- 31.12.2024. * The individual has answered in the recruitment call that he/she is currently using statins or has been prescribed statins in the past 3 years. * Has familiar hypercholesterolemia (APOB, PCSK9, LDLR genes verified by the Estonian biobank) * Is currently participating in other clinical trials. * Has been taking investigative trial medication during the past 30 days prior to study inclusion. * Co-morbid physical or mental il…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to the first occurrence of Major Adverse Cardiovascular Events (MACE).

Timeframe: From enrollment to three years after the end of treatment.

Trial details

NCT IDNCT06820086

SponsorMikk JÜRISSON

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03

View on ClinicalTrials.gov More PRS-based Primary Prevention of CVD trials