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

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Colchicine; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• High polygenic risk for coronary artery disease

• Subclinical atherosclerosis defined as plaque visible on coronary computed tomography angiography and causing <70% luminal stenosis

Exclusion Criteria:

• Cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease

• Contraindication to taking colchicine or rosuvastatin (allergy, liver or kidney disease)

• Taking LDL cholesterol lowering or anti- inflammatory medications

• Contraindications to coronary computed tomography angiography (chronic kidney disease, contrast allergy)

• Pregnancy or breastfeeding

• Inability to provide informed consent

• Estimated glomerular filtration rate <60 mL/min/1.73 m2

• Allergy to iodinated contrast

• BMI ≥ 40 kg/m2

• Inability to hold breath for 10 seconds.