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The Pragmatic EE-PRS Trial assessing Polygenic Risk Driven Statin Therapy for Cardiovascular Disease Prevention
EU CTIS ID: 2024-513424-42-01
What this study is testing
To assess the effectiveness of preventive statin treatment based on high coronary artery disease polygenic risk (CAD PRS) on reducing the incidence of cardiovascular events and death.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men aged 45-80 on 1st of January 2025
- Women aged 55-80 on 1st of January 2025
- CAD PRS top 20% confirmed by the Estonian Biobank
- 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
You likely can't join if
- - 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.
- - Co-morbid physical or mental illnesses that prevent the individual from granting consent or participating in the trial (according to the judgement of the investigator).
- - Individuals taking: a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C); ciclosporin fusidic acid orally or by injection.
- - Has familiar hypercholesterolemia (APOB, PCSK9, LDLR genes verified by the Estonian biobank)
- - Is currently participating in other clinical trials.
See the full eligibility criteria
- Men aged 45-80 on 1st of January 2025
- Women aged 55-80 on 1st of January 2025
- CAD PRS top 20% confirmed by the Estonian Biobank
- 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
- - 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.
- - Co-morbid physical or mental illnesses that prevent the individual from granting consent or participating in the trial (according to the judgement of the investigator).
- - Individuals taking: a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C); ciclosporin fusidic acid orally or by injection.
- - 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.
- - Individuals with a substance abuse disorder (alcohol, narcotic substances).
- - Individuals with hypersensitivity to the active substance (rosuvastatin or atorvastatin) or its excipients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.