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

23.0001

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.

2024-03-01

2029-01-31

2029-01-31

Recruiting

Early phase I

200

Inclusion Criteria: 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. Exclusion Criteria: 1. coronary/PAD/carotid revascularization or ischemic stroke or TIA within 6 months prior to enrollment 2. Valvular heart disease of moderate or worse severity or requiring interventional procedures or surgery 3. LVEF \<35% in the past 12 months 4. Pulmonary hypertension with PASP\>50 mm Hg in the past 12 months 5. Myocarditis or pericarditis in the past 12 months 6. Known Cardiomyopathy (hypertrophic, infiltrative, restrictive, dilated, etc.) 7. Heart failure NYHA class 3 or 4 8. Hospitalization for heart failure in the preceding 6 months 9. Life expectancy of \<1 year 10. An organ-transplant recipient or if felt to require listing for solid organ transplantation during study status 11. Inability to give informed consent 12. Active malignancy (except basal cell skin cancer) 13. Cirrhosis 14. ESRD 15. Pregnancy or planning to conceive during the study period 16. Known intolerance or perceived contraindication to any of the study drugs during the study period including statins or aspirin if indicated 17. eGFR\<30 ml/min/m2 18. Inability to receive iodinated contrast for CCTA 19. Chronic immunosuppression therapy 20. Uncontrolled psychiatric illness

{'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'}}

2024-04-25