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

March 13, 2025 updated by: Dinesh Kalra, MD, University of Louisville
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

ART-CAP (Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque ) is a prospective randomized open-label trial with blinded end-point. This research project aims to study the role of coronary computed tomographic angiography (CCTA) as a superior guide for the direct assessment and monitoring of the impact of preventive cardiovascular drugs on coronary artery plaque for better clinical decision-making and improving patient outcomes. Participants aged 18-80 years, at intermediate or high-risk (10-year ASCVD risk of 5-20% or >20%; calculated based on age, gender, race, history of smoking, diabetes mellitus, hypertension, hyperlipidemia, and family history of premature CAD, with/without symptoms suggestive of coronary disease) who has non-obstructive plaque on CCTA (stenosis of 0-39% or 40-69% with FFR-CT >0.8), will be enrolled. Participants with a history of heart attack, coronary stents or bypass surgery, recent stroke, severe valvular heart disease, pulmonary hypertension, NYHA class 3 or 4 heart failure, recent heart failure hospitalization, active cancer, life expectancy of <1 year, end-stage kidney or liver disease, pregnancy or uncontrolled psychiatric illness, will be excluded.

Participants will be randomly assigned to two groups - Standard of Care (SOC, 100 pts) vs. Aggressive Therapy (AT, 100 pts). Both groups will receive dietary and lifestyle interventions. SOC will be treated with statin and/or aspirin as per the ACC guidelines. AT group will be treated with statin, aspirin, nexlizet, leqvio, vascepa, jardiance, and colchicine. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. At baseline, participants will undergo Polygenic Risk Score (PRS) and next-generation sequencing (NGS) for a South Asian gene panel. Biomarker evaluations at baseline, 9 months, and 18 months include lipid profiles, inflammatory markers, cardiac biomarkers, and buffy coat analysis for CHIP, along with standard blood tests including CBC and CMP. Additionally, echocardiographic evaluation will be performed at baseline and 18 months.

After 18 months of medical treatment, a repeat CCTA will be performed to evaluate primary endpoints of the percentage change in plaque burden (total, non-calcified and calcified), plaque characteristics including high-risk features, ischemia value for the most severe lesion, and pericoronary/epicardial fat attenuation. Patient will be followed for additional 5 years for MACCE (major adverse cardiovascular and cerebrovascular events).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine, Division of Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Statin
high intensity statin (eg atorvastatin 80 mg daily)
Other Names:
  • atorvastatin
Drug: Aspirin tablet
aspirin 81 mg po qd
Other Names:
  • aspirin 81 mg
Experimental: AT: Statin, Aspirin, Nexlizet, Leqvio, Vascepa, Jardiance, Colchicine
An AT group: FDA-approved drugs will be used to reduce cholesterol and cardiovascular risk.
Drug: Statin
high intensity statin (eg atorvastatin 80 mg daily)
Other Names:
  • atorvastatin
Drug: Aspirin tablet
aspirin 81 mg po qd
Other Names:
  • aspirin 81 mg
Drug: Nexlizet
bempedoic acid-ezetimibe 180-10 mg po qd
Other Names:
  • bempedoic acid-ezetimibe
Drug: LEQVIO
inclisiran SQ as per product insert
Other Names:
  • inclisiran
Drug: Vascepa
icosapent ethyl 2g PO BID
Other Names:
  • icosapent ethyl
Drug: Jardiance
empagliflozin 10 mg PO QD
Other Names:
  • empagliflozin
Drug: Colchicine
Colchicine 0.5 MG po qd

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plaque quantification
Time Frame: Baseline, 18 months
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
Time Frame: Baseline, 18 months
Characterization of plaque to evaluate for high-risk features - positive remodeling Units: no units (yes or no)
Baseline, 18 months
Quantification of stenosis
Time Frame: Baseline, 18 months
Quantification of stenosis by using CT-FFR. Unit: percentage
Baseline, 18 months
Quantification of pericoronary fat attenuation.
Time Frame: Baseline, 18 months
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
Time Frame: Baseline, 18 months
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
Time Frame: Baseline, 18 months
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.
Time Frame: Baseline, 18 months
Quantification of epicardial fat attenuation. Unit: Fat attenuation index [ranging from -190 to -30 Hounsfield units (HU)]
Baseline, 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cardiovascular events (MACCE)
Time Frame: 5 years

Number of participants with adjusted events including non-fatal myocardial infarction, stroke, transient ischemic attack, urgent revascularization, cardiovascular hospitalization, hospitalization for heart failure, and cardiovascular death.

Unit: number of events
5 years
Polygenic risk score (PRS)
Time Frame: Baseline

Polygenic risk score (PRS) to estimate the participant's genetic susceptibility for coronary artery disease, assessed via blood draw.

Unit: No units (weighted score ranging from 0-100)
Baseline
Next generation sequencing (NGS)
Time Frame: Baseline

Next generation sequencing (NGS) to identify mutations associated with coronary artery disease, assessed via blood draw.

Unit: Mutation in disease-genes
Baseline
Change in Lipoprotein (a)
Time Frame: Baseline, 9 and 18 months
Change in Lipoprotein (a) level as assessed via blood draw. Unit: nmol/L
Baseline, 9 and 18 months
Change in myeloperoxidase (MPO) activity
Time Frame: Baseline, 9 and 18 months
Change in myeloperoxidase (MPO) activity, as assessed via blood draw. Unit: μU/mg
Baseline, 9 and 18 months
Change in trimethylamine-N-oxide (TMAO) levels
Time Frame: Baseline, 9 and 18 months
Change in trimethylamine-N-oxide (TMAO) levels, assessed via blood draw. Unit: µM
Baseline, 9 and 18 months
Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels
Time Frame: Baseline, 9 and 18 months

Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, as assessed by blood draw.

Unit: ng/mL
Baseline, 9 and 18 months
Change in interleukin-6 (IL-6) levels
Time Frame: Baseline, 9 and 18 months
Change in interleukin-6 (IL-6) levels, as assessed by blood draw. Unit: pg/mL
Baseline, 9 and 18 months
Change in high sensitivity C-creative protein (HS-CRP) levels
Time Frame: Baseline, 9 and 18 months

Change in high sensitivity C-creative protein (HS-CRP) levels as assessed by blood draw.

Units: mg/mL
Baseline, 9 and 18 months
Buffy coat for chromatin immunoprecipitation (ChIP)
Time Frame: Baseline, 9 and 18 months
Buffy coat for chromatin immunoprecipitation (ChIP) as assessed by blood draw. Unit: Genomic locations of binding of various proteins involved in coronary plaque formation
Baseline, 9 and 18 months
Change in high sensitivity Troponin (HS-Tn)
Time Frame: Baseline, 9 and 18 months
Change in high sensitivity Troponin (HS-Tn), as assessed by blood draw. Unit: ng/mL
Baseline, 9 and 18 months
Change in natriuretic peptide (BNP, NT-pro BNP
Time Frame: Baseline, 9 and 18 months
Change in natriuretic peptide (BNP, NT-pro BNP), as assessed by blood draw. Unit: pg/mL
Baseline, 9 and 18 months
Change in levels of open reading frame 1 protein (ORF1p)
Time Frame: Baseline, 9 and 18 months

Change in levels of open reading frame 1 protein (ORF1p), as assessed by blood draw using enzyme-linked immunosorbent assay (ELISA) or western blotting.

Unit: μg/mL
Baseline, 9 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Louisville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dinesh Kalra, MD, University of Louisville School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23.0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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