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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
The main question PROACT 2 aims to answer is whether and how single or dual targeting of cholesterol-lowering and inflammation modulates coronary plaque in individuals with high polygenic risk and subclinical coronary atherosclerosis.
This is a double-blind randomized controlled trial of 200 individuals with high polygenic risk for coronary artery disease and subclinical plaque on coronary computed tomography angiography. Participants will be randomized into four equal treatment groups: group A receiving a placebo daily, group B receiving rosuvastatin 20mg daily, group C receiving colchicine 0.6mg daily, and group D receiving both rosuvastatin 20mg daily and colchicine 0.6mg daily. The primary outcome is change in total non-calcified plaque volume on coronary computed tomography angiography from baseline to one year. Multiple secondary plaque imaging and biomarker outcomes will be explored in this pilot mechanistic trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Placebo Comparator | Participants will receive placebo daily |
|
| Group B | Active Comparator | Participants will receive rosuvastatin 20mg daily and placebo daily |
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| Group C | Active Comparator | Participants will receive colchicine 0.6mg daily and placebo daily |
|
| Group D | Active Comparator | Participants will receive rosuvastatin 20mg daily and colchicine 0.6mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Pharmacotherapy for reduction in LDL cholesterol level |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41706060 | Derived | Abou-Karam R, Kim MS, Jemma Cho SM, Bitar F, Gady S, Cheng F, Thompson AG, Karlson EW, Natarajan P, Ellinor PT, Foldyna B, Ghebremichael MS, Atlas SJ, Ridker PM, Lu MT, Fahed AC. Polygenic Risk Based Detection and Treatment of Subclinical Coronary Atherosclerosis in the PROACT Clinical Trials. J Am Coll Cardiol. 2026 Feb 6:S0735-1097(25)10563-9. doi: 10.1016/j.jacc.2025.12.032. Online ahead of print. |
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Data will be tabulated and analyzed. Study site will not share any of the subject identifiers.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Colchicine | Drug | Pharmacotherapy for inflammation inhibition |
|
| Placebo | Drug | Capsule with sugar pill that mimics active study drugs |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000470 | Alkaloids |