Do stAtins faVourably modify atherosclerotIc plaque in patients with differeNt levels of polygenic Cardiovascular (CV) rIsk?

Monash University0 个研究点目标入组 600 人开始时间: 2020年11月6日最近更新: 2022年3月7日

适应症

试验速览

暂无简介。

•1.Capable of providing written informed consent and willing to adhere to all protocol requirements
•2.Male or female 18 years and over
•3.Established coronary atherosclerosis on a clinically indicated Computed Tomography Coronary Angiogram (CTCA)
•a.Stenosis diameter 20 – 50% in a major epicardial artery
•b.Quality of imaging acceptable to imaging core laboratory
•4.Low density lipoprotein cholesterol (LDL-C) >1.8mmol/L
•5.Able to have a polygenic risk score (PRS) calculated
•6.Female participants must not be pregnant, breastfeeding or plan to become pregnant during the study. Female participants of childbearing potential must have a negative urine pregnancy test at the Screening Visit
•7.Investigator believes that the participant is willing to adhere to all protocol requirements, including returning for follow up CTCA.

•1.Unable to provide written informed consent;
•2.Unable or unwilling to adhere to all protocol requirements;
•3.Requirement for lipid lowering therapy;
•4.Hepatic or gall bladder disease;
•5.Body mass index >40kg/m2;
•6.Known contraindication to statin therapy;
•7.Estimated glomerular filtration rate of <60 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;
•8.Anaemia, defined as haemoglobin concentration <11 g/dL for males and haemoglobin concentration <9 g/dL for females;
•9.History of malignancy within the past 5 years, with the exception of non-melanoma skin cancers;
•10.Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study;
•11.Already participating in another trial involving the use of a study drug

发起方