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

Phase 2

Recruiting

• Conditions: Cardiovascular disease; Coronary atherosclerosis; Polygenic risk; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12620001166965
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in non-calcified plaque volume, with Bonferroni correction assessed on changes between baseline and follow up CT coronary angiogram imaging.[The outcome will be assessed at 18 months from the baseline CT coronary angiogram. ]

Secondary Outcome Measures

Name	Time	Method
Changes in total atheroma volume assessed on CT coronary angiogram.<br><br>[Assessed at 18 months, end of study.];Changes in calcified plaque volume assessed on CT coronary angiogram.[Assessed at 18months, end of study.];Changes in percent atheroma volume assessed on CT coronary angiogram.[Assessed at 18months, at end of study];Changes in maximum lumen stenosis assessed on CT coronary angiogram.[Assessed at 18 months, end of study.];Changes in Leaman score assessed on CT coronary angiogram.[Assessed at 18 months, end of study.];Changes in fat attenuation index assessed on CT coronary angiogram.[Assessed at 18 months, end of study.]