The main question PROACT 2 aims to answer is whether and how 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 150 individuals with high polygenic risk for coronary artery disease and subclinical plaque on coronary computed tomography angiography. Participants will be randomized in a 1:1 allocation to rosuvastatin 20mg and colchicine 0.6mg daily vs. rosuvastatin 20mg and placebo. The primary outcome is change in total non-calcified plaque volume on coronary computed tomography angiography from baseline to one year. Multiple secondary plaque imaging and biomarker outcomes will be explored in this pilot mechanistic trial.
The goal of this double-blind randomized controlled trial is to determine if combination therapy of statin and low-dose colchicine - compared with statin alone - favorably modulates progression and composition of subclinical coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease.