RecruitingPhase 2Phase 3ACTRN12620001166965

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


Sponsor

Monash University

Enrollment

600 participants

Start Date

Sep 2, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates whether statin medications — widely used to lower cholesterol — can reduce the build-up of plaque in the coronary arteries of the heart, and whether this effect differs based on a person's genetic risk for heart disease. Coronary atherosclerosis (plaque in the arteries) is the main cause of heart attacks. Statins are one of the most-prescribed drugs in the world, but their effects on plaque composition and burden can vary between individuals. Using CT coronary angiography (a specialised X-ray scan of the heart's arteries), the study will measure plaque size and type before and after 12 months of statin treatment, comparing results between people with different genetic risk scores. Participants are randomly assigned to receive either a statin or a placebo in a double-blind design — neither they nor their doctors will know which they receive until the study ends. You may be eligible if you are 18 or older, have established coronary atherosclerosis on a clinically ordered CT scan (with mild narrowing of a major artery), have an LDL cholesterol above 1.8 mmol/L, and currently have no requirement for cholesterol-lowering therapy. Pregnant or breastfeeding women, people with liver or gallbladder disease, BMI over 40, or significant kidney impairment are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(6)

Monash Medical Centre - Clayton campus - Clayton

NSW,NT,SA,WA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,NT,SA,WA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,NT,SA,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,NT,SA,WA,VIC, Australia

Royal Darwin Hospital - Tiwi

NSW,NT,SA,WA,VIC, Australia

Frankston Hospital - Frankston

NSW,NT,SA,WA,VIC, Australia

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ACTRN12620001166965


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