None listed
Conditions
Brief summary
This study will be a placebo-controlled, double-blind, randomised Phase 2b/3 study in participants with established cardiovascular disease to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores using CT coronary angiogram. The study will take place at ten sites in Australia.
Interventions
Participants with established cardiovascular disease, determined through a clinically indicated CT coronary angiogram (CTCA) will be enrolled into the study to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores.
Participants will be randomised to receive atorvastatin 40mg or placebo tablet to be taken orally, once daily for 18months. Participants will be asked to return unused tablets to monitor adherence to t
Participants with established cardiovascular disease, determined through a clinically indicated CT coronary angiogram (CTCA) will be enrolled into the study to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores. Participants will be randomised to receive atorvastatin 40mg or placebo tablet to be taken orally, once daily for 18months. Participants will be asked to return unused tablets to monitor adherence to the intervention. They will undergo a second CTCA to determine changes to coronary plaque burden at 18 months.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed