Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

NCT06280976 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 23.0001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Atherosclerosis; Heart Attack

Keywords

Coronary artery plaque; Coronary CT angiogram

Outcome Measures

Primary Outcomes (7)

• Plaque quantification

  Quantification of plaque including total plaque, calcified plaque, non-calcified plaque, and partially calcified plaque. Units: mm3

  Baseline, 18 months

• Characterization of plaque to evaluate for high-risk features - positive remodeling

  Characterization of plaque to evaluate for high-risk features - positive remodeling Units: no units (yes or no)

  Baseline, 18 months

• Quantification of stenosis

  Quantification of stenosis by using CT-FFR. Unit: percentage

  Baseline, 18 months

• Quantification of pericoronary fat attenuation.

  Quantification of pericoronary and epicardial fat attenuation. Unit: Fat attenuation index \[ranging from -190 to -30 Hounsfield units (HU)\]

  Baseline, 18 months

• Characterization of plaque to evaluate for high-risk features - low CT attenuation

  Characterization of plaque to evaluate for high-risk features - low CT attenuation Units: no units (yes or no)

  Baseline, 18 months

• Characterization of plaque to evaluate for high-risk features - napkin-ring sign

  Characterization of plaque to evaluate for high-risk features - napkin-ring sign Units: no units (yes or no)

  Baseline, 18 months

• Quantification of epicardial fat attenuation.

  Quantification of epicardial fat attenuation. Unit: Fat attenuation index \[ranging from -190 to -30 Hounsfield units (HU)\]

  Baseline, 18 months

Secondary Outcomes (13)

• Major adverse cardiac and cardiovascular events (MACCE)

  5 years

• Polygenic risk score (PRS)

  Baseline

• Next generation sequencing (NGS)

  Baseline

• Change in Lipoprotein (a)

  Baseline, 9 and 18 months

• Change in myeloperoxidase (MPO) activity

  Baseline, 9 and 18 months

Study Arms (2)

SOC: Statin ± Aspirin (per ACC guidelines)

ACTIVE COMPARATOR

The SOC group: participant receive routine care as per cardiologist. Study doctor will prescribe medications that they choose themselves.

Drug: Statin; Drug: Aspirin tablet

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

EXPERIMENTAL

An AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk.

Drug: Statin; Drug: Aspirin tablet; Drug: Nexlizet; Drug: LEQVIO; Drug: Vascepa; Drug: Jardiance; Drug: Colchicine

Interventions

Statin DRUG

high intensity statin (eg atorvastatin 80 mg daily)

Also known as: atorvastatin

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine; SOC: Statin ± Aspirin (per ACC guidelines)

Aspirin tablet DRUG

aspirin 81 mg po qd

Also known as: aspirin 81 mg

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine; SOC: Statin ± Aspirin (per ACC guidelines)

Nexlizet DRUG

bempedoic acid-ezetimibe 180-10 mg po qd

Also known as: bempedoic acid-ezetimibe

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

LEQVIO DRUG

inclisiran SQ as per product insert

Also known as: inclisiran

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

Vascepa DRUG

icosapent ethyl 2g PO BID

Also known as: icosapent ethyl

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

Jardiance DRUG

empagliflozin 10 mg PO QD

Also known as: empagliflozin

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

Colchicine DRUG

Colchicine 0.5 MG po qd

AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-obstructive atherosclerotic coronary artery plaque (stenosis of 0-39% or stenosis of 40-69% with FFR-CT \>0.8) in a major epicardial vessel \> 2 mm in diameter.

You may not qualify if:

• coronary/PAD/carotid revascularization or ischemic stroke or TIA within 6 months prior to enrollment
• Valvular heart disease of moderate or worse severity or requiring interventional procedures or surgery
• LVEF \<35% in the past 12 months
• Pulmonary hypertension with PASP\>50 mm Hg in the past 12 months
• Myocarditis or pericarditis in the past 12 months
• Known Cardiomyopathy (hypertrophic, infiltrative, restrictive, dilated, etc.)
• Heart failure NYHA class 3 or 4
• Hospitalization for heart failure in the preceding 6 months
• Life expectancy of \<1 year
• An organ-transplant recipient or if felt to require listing for solid organ transplantation during study status
• Inability to give informed consent
• Active malignancy (except basal cell skin cancer)
• Cirrhosis
• ESRD
• Pregnancy or planning to conceive during the study period

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville School of Medicine, Division of Cardiovascular Diseases

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Infarction

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Aspirin; ALN-PCS; eicosapentaenoic acid ethyl ester; empagliflozin; Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Alkaloids

Study Officials

• Dinesh Kalra, MD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: PROBE design: Prospective Randomized Open Label Blinded End-point

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)