RecruitingPhase 4NCT05850091

Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine

Sponsor

Massachusetts General Hospital

Enrollment

200 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria10

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 following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome)
Participant with estimated glomerular filtration rate <60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal
Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins
Patient currently taking LDL cholesterol lowering or anti- inflammatory medications including colchicine
Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin)
Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study
Participant with BMI ≥ 40 kg/m2
Participant unable to provide informed consent
Participant unable to hold breath for 10 seconds