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Genetic test guides statin use to prevent heart attacks

NCT ID NCT06820086

Prevention Sponsor: Mikk JÜRISSON Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether giving a daily statin (rosuvastatin 20mg) to healthy people with a high genetic risk for heart disease can prevent major cardiovascular events like heart attacks and strokes. Over 2,700 men and women aged 45-80 with top 20% genetic risk scores are being followed for five years. The goal is to see if this targeted prevention approach works better and is more cost-effective than standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rosuvastatin 20mg
What this could lead to
If successful, this could show that using genetic risk scores to guide statin therapy is an effective and cost-saving way to prevent heart attacks and strokes.
What could go wrong
This is a Phase 4 trial, but it's still early in terms of real-world implementation. The results may not apply to all populations, and statins can have side effects like muscle pain or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,714 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Mar 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

Genetic Risk Score cardiovascular disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PRS-based primary prevention of CVD

Contacts and locations

Locations

  • North Estonia Medical Centre

    Tallinn, Harju, Estonia

  • Tartu University Hospital

    Tartu, Tartu, Estonia