Coronary Artery Disease Clinical Trial
— PROACT 2Official title:
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 2027 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total non-calcified plaque volume from baseline to one 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. | 1 year | |
Secondary | Change in total plaque volumes from baseline to one year | The change in the following plaque volumes will be compared between the two groups from baseline to one year: total plaque volume, total calcified plaque volume, and total low attenuation plaque volume. These volumes will be analyzed individually and reported in cubic millimeters (mm³). | 1 year | |
Secondary | Change in maximal luminal stenosis from baseline to one year | The change in maximal luminal stenosis will be compared between the two groups from baseline to one year, reported as a percentage (%). | 1 year | |
Secondary | Change in calcium score from baseline to one year | The change in calcium score will be compared between the two groups from baseline to one year, reported in Agatston units. | 1 year | |
Secondary | Change in number of high-risk features from baseline to one year | The change in the number of high-risk features will be compared between the two groups from baseline to one year, reported as a count (number of features). | 1 year | |
Secondary | Change in fat attenuation index from baseline to one year | The change in fat attenuation index will be compared between the two groups from baseline to one year, reported in Hounsfield units (HU). | 1 year | |
Secondary | Progression in non-calcified plaque volume from baseline to one year | The proportion of participants who had progression in non-calcified plaque volume from baseline to one year (%) | 1 year | |
Secondary | Change in low-density lipoprotein cholesterol (LDL-C) from baseline to one year | The change in low-density lipoprotein cholesterol (LDL-C) will be compared between the two groups from baseline to one year, reported in milligrams per deciliter (mg/dL). | 1 year | |
Secondary | Change in C-reactive protein (CRP) from baseline to one year | The change in C-reactive protein (CRP) will be compared between the two groups from baseline to one year, reported in milligrams per liter (mg/L). | 1 year | |
Secondary | Change in Interleukin-6 and Interleukin-1 beta (IL-1ß) from baseline to one year | The change in Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1ß) will be compared between the two groups from baseline to one year. Both biomarkers will be analyzed individually and reported in picograms per milliliter (pg/mL). | 1 year |
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