NCT07232069 · Duke University
PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
(PRE-EMPT)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Rosuvastatin 20 Mg Oral Tablet
Statin
DRUG
Colchicine 0.5 MG Oral Tablet Once Daily
Anti-inflammatory
DRUG
Placebo
Placebo, non-active, drug-matched
Primary outcome measures
Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.
Time frame: 2 years
Plaque volume in mm3 in each group
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Women aged 40-60 years; Men aged 30-50 years
- Willing and able to provide informed consent and comply with study procedures
- Smart phone user
- Use of highly effective contraception by females with reproductive potential.
- CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\<100 if known; elevated CAC on baseline CCTA is not
Exclusion criteria
- ary in the known plaque arm)
- Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab Exclusion Criteria:
- Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)
- Current symptoms thought to be from CAD
- PREVENT ASCVD 10-year risk ≥5% (if known)
- Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)
- LDL-C ≥190mg/dL (most recent, if known)
- HIV (if known)
- Severe liver disease or untreated Hepatitis C infection (if known)
- Pregnancy, lactation or intending to become pregnant during the study period of 2 years
- eGFR \<45mL/min/1.73m2 (if known)
- AST or ALT \>1.5x the upper limit of normal (if known)
- BMI\>40kg/m2 or unable to have a CCTA scan for any reason
- Allergy to iodinated intravenous contrast or other contraindication to CCTA
- Current or previous use of lipid lowering therapy or colchicine
- Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.
- Systemic cancer undergoing active treatment
- PREVENT ASCVD 10-year risk ≥5%
- eGFR \<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)
- Hemoglobin A1c ≥6.5% per baseline labs
- LDL-C ≥190mg/dL per baseline labs
- Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)
- Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)
- Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.
Where
- Birmingham, Alabama
- Mobile, Alabama
- Los Angeles, California
- Hiram, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Duluth, Minnesota
- Mount Kisco, New York
- New York, New York
- Durham, North Carolina
- Winston-Salem, North Carolina
And 9 more locations — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, Massachusetts General Hospital, Johns Hopkins University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations