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Clinical trialNCT07232069RecruitingPhase 3Interventional

PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

SponsorDuke UniversityEnrollment1,500Coronary Artery Disease ProgressionCoronary Artery Disease Risk Factors MultiplePremature AtherosclerosisPrevention & Control
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works. PRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called "plaque", in their heart arteries. It consists of two phases: 1. A Screening Study - Participants will be assessed for plaque by one or both of these scans. * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries. * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque. 2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos. * Rosuvastatin 20 mg: a cholesterol-lowering medicine * Colchicine 0.5 mg: a medication that lowers inflammation Everyone in the trial will be given information and advice on heart-healthy diet and lifestyle. Participants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

    Kevin Riggs, MD
    Recruiting
  • Cardiology Associates

    Mobile, Alabama, United States

    Jason Cole, MD
    Not, yet, recruiting
  • Lundquist Institute for Biomedical Innovation at Harbor Ucla Medical Center

    Los Angeles, California, United States

    Matthew Budoff, MD
    Recruiting
  • University of California, Los Angeles

    Los Angeles, California, United States

    Karol Watson, MD
    Not, yet, recruiting
  • Wellstar Kennestone Hospital

    Hiram, Georgia, United States

    Frank Corrigan, MD
    Recruiting
  • University of Chicago

    Chicago, Illinois, United States

    Tamar Polonsky, MD
    Not, yet, recruiting
  • Johns Hopkins University

    Baltimore, Maryland, United States

    Michael Blaha, MD
    Not, yet, recruiting
  • Massachusetts General Hospital Brigham

    Boston, Massachusetts, United States

    Michael Honigberg, MD
    Not, yet, recruiting
  • Essentia Health

    Duluth, Minnesota, United States

    Catherine Benzinger, MD
    Not, yet, recruiting
  • Northern Westchester Hospital

    Mount Kisco, New York, United States

    Dina Katz, MD
    Not, yet, recruiting
  • New York University Langone

    New York, New York, United States

    Harmony Reynolds, MD
    Not, yet, recruiting
  • Weill Cornell Medicine

    New York, New York, United States

    Sam Kim, MD
    Recruiting
  • Duke University Hospital

    Durham, North Carolina, United States

    Nishant Shah, MD
    Recruiting
  • Wake Forest University, Advocate Health

    Winston-Salem, North Carolina, United States

    Michael Shapiro, MD
    Not, yet, recruiting
  • Oregon Health and Sciences University

    Portland, Oregon, United States

    Maros Ferencik, MD
    Not, yet, recruiting
  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

    Chris Chambers, MD
    Not, yet, recruiting
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

    Anum Saeed, MD
    Not, yet, recruiting
  • Medical University of South Carolina (musc)

    Charleston, South Carolina, United States

    Sheldon Litwin, MD
    Not, yet, recruiting
  • Vanderbilt University

    Nashville, Tennessee, United States

    Deepak Gupta, MD
    Not, yet, recruiting
  • Houston Methodist Hospital

    Houston, Texas, United States

    Khurrrram Nasir, MD
    Not, yet, recruiting
  • University of Virginia (uva)

    Charlottesville, Virginia, United States

    Todd Villines, MD
    Not, yet, recruiting
  • Inova Health System

    Fairfax, Virginia, United States

    Jared Spitz, MD
    Not, yet, recruiting
  • Marshfield Clinical Research Institute

    Marshfield, Wisconsin, United States

    Jeff VanWormer
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Colchicine 0.5 MG Oral Tablet Once DailyPlaceboRosuvastatin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
21 Jul 2026
Primary completion
31 Jul 2031
Completion
31 Jul 2031
Last update posted
11 Aug 2026
Registered enrollment
1,500
Registry id
NCT07232069

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.