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.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | 0.5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Inclisiran | Small interfering RNA (siRNA) | — | Subcutaneous |
| Subject | Nexlizet | Unknown | — | Oral |
| Subject | icosapent ethyl | Small molecule | 2 g | Oral |
| Background | Aspirin | Small molecule | 81 mg | Oral |
| Background | Atorvastatin | Small molecule | 80 mg | — |