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

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

Interventions

DRUG

Statin

high intensity statin (eg atorvastatin 80 mg daily)

DRUG

Aspirin tablet

aspirin 81 mg po qd

DRUG

Nexlizet

bempedoic acid-ezetimibe 180-10 mg po qd

DRUG

LEQVIO

inclisiran SQ as per product insert

DRUG

Vascepa

icosapent ethyl 2g PO BID

DRUG

Jardiance

empagliflozin 10 mg PO QD

DRUG

Colchicine

Colchicine 0.5 MG po qd

Sponsors & Collaborators

• University of Louisville

  lead OTHER

Principal Investigators

• Dinesh Kalra, MD · University of Louisville School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2025-01-01

Completion

2025-01-01

FDA Drug

Yes

Countries

• United States

Study Locations