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

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05850091

Run by

Massachusetts General Hospital

People needed

200

Starts

2023-12-07

Expected to finish

2027-06-01

Last updated by the study team

2026-06-12

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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