Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

Launched by MIKK JÜRISSON · Feb 5, 2025

Keywords

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Gender

ALL

Eligibility criteria

• 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.