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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 3

Age range

30 years - 60 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

1500 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Women aged 40-60 years; Men aged 30-50 years
2. Willing and able to provide informed consent and comply with study procedures
3. Smart phone user
4. Use of highly effective contraception by females with reproductive potential.
5. 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 exclusionary in the known plaque arm)
6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab

Exclusion Criteria:

1. Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)
2. Current symptoms thought to be from CAD
3. PREVENT ASCVD 10-year risk ≥5% (if known)
4. 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)
5. LDL-C ≥190mg/dL (most recent, if known)
6. HIV (if known)
7. Severe liver disease or untreated Hepatitis C infection (if known)
8. Pregnancy, lactation or intending to become pregnant during the study period of 2 years
9. eGFR \<45mL/min/1.73m2 (if known)
10. AST or ALT \>1.5x the upper limit of normal (if known)
11. BMI\>40kg/m2 or unable to have a CCTA scan for any reason
12. Allergy to iodinated intravenous contrast or other contraindication to CCTA
13. Current or previous use of lipid lowering therapy or colchicine
14. 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.
15. Systemic cancer undergoing active treatment
16. PREVENT ASCVD 10-year risk ≥5%
17. eGFR \<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)
18. Hemoglobin A1c ≥6.5% per baseline labs
19. LDL-C ≥190mg/dL per baseline labs
20. Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)
21. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)
22. 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (23)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

23 locations

Study team and timeline

Lead sponsor

Duke University

Study start

Jul 21, 2026 Actual

Primary completion

2031-07 Estimated

Study completion

2031-07 Estimated

First posted

Nov 18, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts