Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

Plain-language summary

This study evaluates the use of the statin medicine Rosuvastatin for heart disease prevention in people with a high polygenic risk score. Men aged 45 to 80 and women aged 55 to 80 confirmed by the Estonian Biobank to be in the highest coronary artery disease polygenic risk group can take part. It is a Phase 4 study; it is active, not recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Active, not recruiting

Sponsor

Mikk JÜRISSON

Intervention

Rosuvastatin 20mg

Start date

3/26/2025

Estimated completion

3/1/2034

Countries

Estonia

Related genes

Locations

• Tallinn, Estonia
• Tartu, Estonia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.