Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
NCT ID: NCT05850091
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2023-12-07
2027-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Participants will receive placebo daily
Placebo
Capsule with sugar pill that mimics active study drugs
Group B
Participants will receive rosuvastatin 20mg daily and placebo daily
Rosuvastatin
Pharmacotherapy for reduction in LDL cholesterol level
Placebo
Capsule with sugar pill that mimics active study drugs
Group C
Participants will receive colchicine 0.6mg daily and placebo daily
Colchicine
Pharmacotherapy for inflammation inhibition
Placebo
Capsule with sugar pill that mimics active study drugs
Group D
Participants will receive rosuvastatin 20mg daily and colchicine 0.6mg daily
Rosuvastatin
Pharmacotherapy for reduction in LDL cholesterol level
Colchicine
Pharmacotherapy for inflammation inhibition
Interventions
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Rosuvastatin
Pharmacotherapy for reduction in LDL cholesterol level
Colchicine
Pharmacotherapy for inflammation inhibition
Placebo
Capsule with sugar pill that mimics active study drugs
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Akl C. Fahed, MD, MPH
Interventional Cardiologist
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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2023P000945
Identifier Type: -
Identifier Source: org_study_id
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