Kalp Hastalığından Korunma için Poligenik Riske Dayalı Pragmatik Statin Çalışması

Sade dilde özet

Bu çalışma, kalp hastalığından korunmada Rosuvastatin adlı statin ilacının, poligenik risk skoru yüksek kişilerde kullanımını değerlendiriyor. Çalışmaya, Estonya Biyobankası'nca koroner arter hastalığı poligenik risk skoru en yüksek grupta yer aldığı doğrulanan, 45-80 yaş arası erkekler ve 55-80 yaş arası kadınlar katılabiliyor. Faz 4 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Devam ediyor, katılım kapalı

Sponsor

Mikk JÜRISSON

Müdahale

Rosuvastatin 20mg

Başlangıç

26.03.2025

Tahmini bitiş

01.03.2034

Ülkeler

Estonia

İlgili genler

Merkezler

• Tallinn, Estonia
• Tartu, Estonia

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.