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

This study is looking at how two medicines, rosuvastatin and colchicine, might affect the buildup of plaque in your arteries if you have a high genetic risk for heart disease. Rosuvastatin helps lower cholesterol, and colchicine helps reduce inflammation. You could be eligible if you are between 40 and 75 years old, have a high genetic risk for coronary artery disease (CAD), and have some plaque in your arteries that isn't causing severe blockages. The main goal is to see if these treatments can change the amount of plaque in your arteries after one year. This study is currently recruiting 200 participants.

Study design: This is a double-blind randomized controlled trial with 200 participants. You would be assigned to one of four groups: placebo, rosuvastatin, colchicine, or both rosuvastatin and colchicine.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome is measured at one year, suggesting participants will be followed for at least one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Active, Not Recruiting

PHASE4Ages 40–75InterventionalTreatment

Massachusetts General Hospital

~200 participants

Updated 2026-06-12 on ClinicalTrials.gov

What's tested:RosuvastatinColchicinePlacebo

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in total non-calcified plaque volume from baseline to one year

Measured over 1 year

Conditions

Coronary Artery Disease

Where it's being run

1 sites across 1 states

Massachusetts1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Change in total non-calcified plaque volume from baseline to one year1 year
The primary outcome of this study is the change in total non-calcified plaque volume between the two groups from baseline to one year. This outcome will be measured using coronary computed tomography angiography (CCTA) and reported in cubic millimeters (mm³). The comparison of the changes in non-calcified plaque volume will help assess the effectiveness of the intervention on plaque progression and composition.

Trialytics