Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
Massachusetts General Hospital
Summary
The goal of this double-blind randomized controlled trial is to determine how treatment with high intensity statin, low-dose colchicine, and their combination modulates progression and composition of coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease.
Description
The main question PROACT 2 aims to answer is whether and how single or dual targeting of cholesterol-lowering and inflammation modulates coronary plaque in individuals with high polygenic risk and subclinical coronary atherosclerosis. This is a double-blind randomized controlled trial of 200 individuals with high polygenic risk for coronary artery disease and subclinical plaque on coronary computed tomography angiography. Participants will be randomized into four equal treatment groups: group A receiving a placebo daily, group B receiving rosuvastatin 20mg daily, group C receiving colchicine…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females between 40 and 75 years of age capable and willing to provide informed consent * Participant has high CAD PRS as defined on a clinical test * Participant with subclinical atherosclerosis defined as plaque visible on CCTA and causing \<70% luminal stenosis Exclusion Criteria: * Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease * Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the fol…
Interventions
- DrugRosuvastatin
Pharmacotherapy for reduction in LDL cholesterol level
- DrugColchicine
Pharmacotherapy for inflammation inhibition
- DrugPlacebo
Capsule with sugar pill that mimics active study drugs
Location
- Massachusetts General HospitalBoston, Massachusetts