PRS-based Primary Prevention of CVDPhase 4EE-PRSNCT06820086

Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

A Phase 4 study testing Rosuvastatin 20mg in people with PRS-based Primary Prevention of CVD, run by Mikk JÜRISSON at 2 sites in Estonia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 45 to 80 years
Conditions the study is for: PRS-based Primary Prevention of CVD
What is being tested?: Rosuvastatin 20mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,714 participants
Where: 2 sitesEstonia
Study dates: 26 Mar 2025to Mar 2034
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 15Show fewer

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 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.
Individuals with a substance abuse disorder (alcohol, narcotic substances).
Individuals with hypersensitivity to the active substance (rosuvastatin or atorvastatin) or its excipients.

Trial locations and contacts

2 sites in 1 country.

Estonia2 sites

North Estonia Medical Centre
Tallinn, Harju
Tartu University Hospital
Tartu, Tartu

Other trials in Estonia

About this study

Official title: The Pragmatic EE-PRS Trial Assessing Polygenic Risk Driven Statin Therapy for Cardiovascular Disease Prevention

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.

Conditions: PRS-based Primary Prevention of CVD
Being tested: Rosuvastatin 20mg
Keywords: Polygenic Risk Score, Statin Treatment for Primary Prevention, High Polygenic Risk Score for Coronary Artery Disease
Medical subject headings: Genetic Risk Score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rosuvastatin 20mgDrug
Preventive statin treatment with rosuvastatin 20mg, 1 tablet per day, for healthy individuals with top 20% CAD PRS.

Study groups in NCT06820086
Study group	Role	What they receive
Intervention arm receiving statin treatment	Experimental	Intervention arm participants (n=1350) comprise healthy men aged 45- 80 years and women aged 55-80 years with a high (top 20%) coronary artery disease (CAD) polygenic risk score. They are prescribed by their primary care physician the trial medication, rosuvastatin 20mg, 1 tablet per day, for the entire duration of the trial. Intervention arm participants will be measured and regular blood analyses will be taken throughout the trial. They will be having regular primary care visits with their family physician and telemedicine visits with study nurses. Receives: Drug: Rosuvastatin 20mg
Control arm	No intervention	Control arm participants (n=1350) comprise healthy men aged 45- 80 years and women aged 55-80 years with a high (top 20%) coronary artery disease (CAD) polygenic risk score. Participants in the control arm of the trial will be following regular primary care as their family doctors will not be informed of their patients' participation in the trial. This means that in the control arm real-life primary care activities will take place including potential cholesterol-lowering treatment based on the current treatment and prevention guidelines. At the end of the trial, physicians will be informed about their patients who were in the control arm for scheduling a final study visit and ordering a blood test. During the final trial visit the physicians will inform participants of their CAD PRS, provide counselling and take final measurements.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to the first occurrence of Major Adverse Cardiovascular Events (MACE).
Time to the first occurrence of Major Adverse Cardiovascular Events (MACE), ICD-10 codes: ischaemic heart disease (I20-I25), stroke or transient ischemia (I60-64, I69, G45), peripheral vascular occlusion (I65-66, I67.2, I70, I73.9), revascularization (Z95.1, Z95.5, Z95.8, Z95.9) or cardiovascular death (I00-78) from baseline.
Measured: From enrollment to three years after the end of treatment.

Secondary outcomes (12)

Incidence rate of death from any cause among the study participants
Measured: From enrollment to three years after the end of treatment.
Difference in CVD risk factors from baseline by the end of the trial in the intervention and control arm;
Difference in CVD risk factors from baseline (LDL-cholesterol, blood pressure, BMI, waist circumference, smoking, alcohol consumption prevalence) by the end of the trial comparing the intervention and control arm;
Measured: From enrollment to the end of treatment at 5 years.
Treatment adherence in the intervention arm.
Treatment adherence in the intervention arm based on prescriptions and purchases of statins (C10AA, C10BA) and self-reporting using the MARS-5 scale
Measured: From enrollment to the end of treatment at 5 years.
Fidelity of intervention implementation.
Intervention fidelity will be calculated as a composite score by combining adherence rates (proportion of prescribed activities completed) and participant feedback (average satisfaction and engagement ratings from online questionnaires).
Measured: From enrollment to the end of treatment at 5 years.
Acceptability of the primary prevention program across study participants measured using an online questionnaire assessing satisfaction, perceived relevance, and ease of participation.
Measured: From first study visit to the end of treatment at 5 years.
Satisfaction with study processes and results measured using an online questionnaire assessing satisfaction, perceived relevance, and ease of participation.
Measured: From study enrollment to the end of treatment at 5 years.
Difference in plasma concentrations of rosuvastatin.
Difference in plasma concentrations of rosuvastatin comparing study participants with and without a mutation in the SLCO1B1, ABCG2, CYP2C9, CYP2C19, UGT-d, SLCO1B3, SLCO2B1, ABCC2, ABCB11 genes.
Measured: From enrollment to month 3 of treatment.
Difference in rosuvastatin side effects.
Difference in rosuvastatin side effects between study participants with and without a mutation in the SLCO1B1, ABCG2, CYP2C9, CYP2C19, UGT-d, SLCO1B3, SLCO2B1, ABCC2, ABCB11 genes.
Measured: From enrollment to the end of treatment at 5 years.
Number of participants with adverse events and serious adverse events from statin therapy.
Measured: From enrollment to the end of treatment at 5 years.
Utilisation of healthcare resources evaluated through a cost-utilty model
Data on healthcare resource utilization, including non-trial physician and cardiologist visits, hospitalizations, length of stay, informal care, and direct healthcare costs, will be aggregated to develop a cost-utility model.
Measured: From enrollment to the end of treatment at 5 years.
Number of participants who withdrew or dropped out from the study.
Measured: From enrollment to the end of treatment at 5 years.
Utilities from the EQ-5L-5D surveys and productivity costs from the iPCQ survey for calculating quality-adjusted life years (QALY) gained over a lifetime, incremental cost-effectiveness ratio (ICER).
Measured: From enrollment to the end of treatment at 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 2025Mar 2034

First posted11 Feb 2025
Study start26 Mar 2025
Primary completionMar 2031 (estimated)
Study completionMar 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PRS-based Primary Prevention of CVDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,714 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06820086
Sponsor's protocol ID: EEPRS12308
Other IDs: 2024-513424-42-01
Acronym: EE-PRS
Status last verified: May 2026
First submitted: 22 Jan 2025
Last updated: 13 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Voit A, Elken A, Viigimaa M, Kalda R, Fischer K, Toompere K, Irs A, Milani L, Alavere H, Pajusalu S, Org E, Alloja J, Kaarna K, Jurisson M. Pragmatic trial assessing polygenic risk driven statin therapy for cardiovascular disease prevention: study protocol for the EE-PRS trial. BMJ Open. 2026 May 27;16(5):e120048. doi: 10.1136/bmjopen-2026-120048.
PubMed 42203295

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Pragmatic EE-PRS Trial Assessing Polygenic Risk Driven Statin Therapy for Cardiovascular Disease Prevention
ClinicalTrials.gov ID: NCT06820086
Acronym / sponsor ID: EE-PRS / EEPRS12308
Conditions: PRS-based Primary Prevention of CVD
Keywords: Polygenic Risk Score, Statin Treatment for Primary Prevention, High Polygenic Risk Score for Coronary Artery Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,714 participants (actual)
Lead sponsor: Mikk JÜRISSONUniversity, hospital or other
Collaborators: European Union, The Estonian Health Insurance Fund, North Estonian Medical Center, Tartu University Hospital
Study start: 26 Mar 2025 (actual)
Primary completion: Mar 2031 (estimated)
Study completion: Mar 2034 (estimated)
First posted: 11 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention arm receiving statin treatment	Experimental	Drug: Rosuvastatin 20mgIntervention arm participants (n=1350) comprise healthy men aged 45- 80 years and women aged 55-80 years with a high (top 20%) coronary artery disease (CAD) polygenic risk score. They are prescribed by their primary care physician the trial medication, rosuvastatin 20mg, 1 tablet per day, for the entire duration of the trial. Intervention arm participants will be measured and regular blood analyses will be taken throughout the trial. They will be having regular primary care visits with their family physician and telemedicine visits with study nurses.
Control arm	No intervention	–Control arm participants (n=1350) comprise healthy men aged 45- 80 years and women aged 55-80 years with a high (top 20%) coronary artery disease (CAD) polygenic risk score. Participants in the control arm of the trial will be following regular primary care as their family doctors will not be informed of their patients' participation in the trial. This means that in the control arm real-life primary care activities will take place including potential cholesterol-lowering treatment based on the current treatment and prevention guidelines. At the end of the trial, physicians will be informed about their patients who were in the control arm for scheduling a final study visit and ordering a blood test. During the final trial visit the physicians will inform participants of their CAD PRS, provide counselling and take final measurements.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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:
Has familiar hypercholesterolemia (APOB, PCSK9, LDLR genes verified by the Estonian biobank)
Is currently participating in other clinical trials.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rosuvastatin 20mgPreventive statin treatment with rosuvastatin 20mg, 1 tablet per day, for healthy individuals with top 20% CAD PRS.	Drug	Intervention arm receiving statin treatment

Primary outcome

Time to the first occurrence of Major Adverse Cardiovascular Events (MACE).
Time frame: From enrollment to three years after the end of treatment.
Time to the first occurrence of Major Adverse Cardiovascular Events (MACE), ICD-10 codes: ischaemic heart disease (I20-I25), stroke or transient ischemia (I60-64, I69, G45), peripheral vascular occlusion (I65-66, I67.2, I70, I73.9), revascularization (Z95.1, Z95.5, Z95.8, Z95.9) or cardiovascular death (I00-78) from baseline.

12 secondary outcomes

Incidence rate of death from any cause among the study participants
Time frame: From enrollment to three years after the end of treatment.
Difference in CVD risk factors from baseline by the end of the trial in the intervention and control arm;
Time frame: From enrollment to the end of treatment at 5 years.
Treatment adherence in the intervention arm.
Time frame: From enrollment to the end of treatment at 5 years.
Fidelity of intervention implementation.
Time frame: From enrollment to the end of treatment at 5 years.
Acceptability of the primary prevention program across study participants measured using an online questionnaire assessing satisfaction, perceived relevance, and ease of participation.
Time frame: From first study visit to the end of treatment at 5 years.
Satisfaction with study processes and results measured using an online questionnaire assessing satisfaction, perceived relevance, and ease of participation.
Time frame: From study enrollment to the end of treatment at 5 years.
Difference in plasma concentrations of rosuvastatin.
Time frame: From enrollment to month 3 of treatment.
Difference in rosuvastatin side effects.
Time frame: From enrollment to the end of treatment at 5 years.
Number of participants with adverse events and serious adverse events from statin therapy.
Time frame: From enrollment to the end of treatment at 5 years.
Utilisation of healthcare resources evaluated through a cost-utilty model
Time frame: From enrollment to the end of treatment at 5 years.
Number of participants who withdrew or dropped out from the study.
Time frame: From enrollment to the end of treatment at 5 years.
Utilities from the EQ-5L-5D surveys and productivity costs from the iPCQ survey for calculating quality-adjusted life years (QALY) gained over a lifetime, incremental cost-effectiveness ratio (ICER).
Time frame: From enrollment to the end of treatment at 5 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Derived from this study: PubMed 42203295Voit A, Elken A, Viigimaa M, Kalda R, Fischer K, Toompere K, Irs A, Milani L, Alavere H, Pajusalu S, Org E, Alloja J, Kaarna K, Jurisson M. Pragmatic trial assessing polygenic risk driven statin therapy for cardiovascular disease prevention: study protocol for the EE-PRS trial. BMJ Open. 2026 May 27;16(5):e120048. doi: 10.1136/bmjopen-2026-120048.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mikk Jürisson, PhD study director

Institute of Family Medicine and Public Health, University of Tartu

Aet Elken (Saar), PhD principal investigator

Heart Clinic, Tartu University Hospital

Margus Viigimaa, PhD principal investigator

North Estonia Medical Centre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin 20mg in people with PRS-based Primary Prevention of CVD, run by Mikk JÜRISSON at 2 sites in Estonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the first occurrence of Major Adverse Cardiovascular Events (MACE). (time frame: From enrollment to three years after the end of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06820086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.