Do stAtins faVourably modify atherosclerotIc plaque in patients with differeNt levels of polygenic Cardiovascular (CV) rIsk?
Monash University
600 participants
Sep 2, 2021
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
Plain Language Summary
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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 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)
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ACTRN12620001166965