protocolSection identificationModule nctId: NCT06280976, orgStudyIdInfo id: 23.0001, briefTitle: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP), acronym: ARTCAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-01-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat., conditionsModule conditions: Coronary Artery Disease, conditions: Atherosclerosis, conditions: Heart Attack, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PROBE design: Prospective Randomized Open Label Blinded End-point, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Statin, interventions name: Aspirin tablet, interventions name: Nexlizet, interventions name: LEQVIO, interventions name: Vascepa, interventions name: Jardiance, interventions name: Colchicine, outcomesModule primaryOutcomes measure: Plaque quantification, primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - positive remodeling, primaryOutcomes measure: Quantification of stenosis, primaryOutcomes measure: Quantification of pericoronary fat attenuation., primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - low CT attenuation, primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - napkin-ring sign, primaryOutcomes measure: Quantification of epicardial fat attenuation., secondaryOutcomes measure: Major adverse cardiac and cardiovascular events (MACCE), secondaryOutcomes measure: Polygenic risk score (PRS), secondaryOutcomes measure: Next generation sequencing (NGS), secondaryOutcomes measure: Change in Lipoprotein (a), secondaryOutcomes measure: Change in myeloperoxidase (MPO) activity, secondaryOutcomes measure: Change in trimethylamine-N-oxide (TMAO) levels, secondaryOutcomes measure: Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, secondaryOutcomes measure: Change in interleukin-6 (IL-6) levels, secondaryOutcomes measure: Change in high sensitivity C-creative protein (HS-CRP) levels, secondaryOutcomes measure: Buffy coat for chromatin immunoprecipitation (ChIP), secondaryOutcomes measure: Change in high sensitivity Troponin (HS-Tn), secondaryOutcomes measure: Change in natriuretic peptide (BNP, NT-pro BNP, secondaryOutcomes measure: Change in levels of open reading frame 1 protein (ORF1p), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Dinesh Kalra, MD, role: CONTACT, phone: 502-588-7010, email: diniesh.kalra@louisville.edu, contacts name: Muhammad Umer, MD, role: CONTACT, phone: 502-588-7010, email: muhammad.umer.1@louisville.edu, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False