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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06280976
Phase
PHASE4
Status
Withdrawn

Conditions

  • Atherosclerosis
  • Coronary Artery Disease
  • Heart Attack

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Statin — DRUG
    high intensity statin (eg atorvastatin 80 mg daily)
  • Aspirin tablet — DRUG
    aspirin 81 mg po qd
  • Nexlizet — DRUG
    bempedoic acid-ezetimibe 180-10 mg po qd
  • LEQVIO — DRUG
    inclisiran SQ as per product insert
  • Vascepa — DRUG
    icosapent ethyl 2g PO BID
  • Jardiance — DRUG
    empagliflozin 10 mg PO QD
  • Colchicine — DRUG
    Colchicine 0.5 MG po qd

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Apr 2024
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SOC: Statin ± Aspirin (per ACC guidelines)
    The SOC group: participant receive routine care as per cardiologist. Study doctor will prescribe medications that they choose themselves.
  • Experimental: AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine
    An AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk.

Primary Outcome Measure

Plaque quantification [ Time Frame: Baseline, 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville School of Medicine, Division of Cardiovascular DiseasesLouisvilleKentucky40202-

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University of Louisville School of Medicine, Division of Cardiovascular Diseases· Louisville, KY

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