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Coronary Artery Disease Risk Factors MultiplePhase 3PRE-EMPTNCT07232069

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

A Phase 3 study testing Rosuvastatin 20 Mg Oral Tablet and Colchicine 0.5 MG Oral Tablet Once Daily in people with Coronary Artery Disease Risk Factors Multiple and Coronary Artery Disease Progression, run by Duke University at 23 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
Rosuvastatin 20 Mg Oral Tablet and Colchicine 0.5 MG Oral Tablet Once Daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,500 participants
Where
23 sitesUnited States
Study dates
21 Jul 2026to Jul 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 exclusionary in the known plaque arm)
  • Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab

Who cannot join

  • 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)
Show all 22Show fewer
  • 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.

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Olson, Project Manager contact

919-309-5544

rachel.e.olson@duke.edu

23 sites in 1 country

United States23 sites, 23 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Prati Pratishruti, MBBS, 410-301-1245, fpratis1@jhu.edu

    Michael Blaha, MD

    Not yet recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Dalton Norwood, 909-786-8315, daltonnorwood@uabmc.edu

    Kevin Riggs, MD

    Recruiting

  • Massachusetts General Hospital Brigham

    Boston, Massachusetts, 02114

    Pearl Lee, MSc, 617-721-7783, plee23@mgh.harvard.edu

    Michael Honigberg, MD

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Melissa Amitrano, MPH, 843-876-5009, amitrano@musc.edu

    Sheldon Litwin, MD

    Not yet recruiting

  • University of Virginia (UVA)

    Charlottesville, Virginia, 22903

    James Ingersoll, 434-982-1058, WFC5KC@uvahealth.org

    Todd Villines, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Tamar Polonsky, MD, 773-702-1409, tpolonsky@bsd.uchicago.edu

    Tamar Polonsky, MD

    Not yet recruiting

  • Essentia Health

    Duluth, Minnesota, 55805

    Martha Vanderlinde, BS, 218-786-2729, Martha.Vanderlinde@essentiahealth.org

    Catherine Benzinger, MD

    Not yet recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Niki Huffman, 919-681-6458, niki.huffman@duke.edu

    Nishant Shah, MD

    Recruiting

  • Inova Health System

    Fairfax, Virginia, 22031

    Mahira Awan, 571-472-8570, mahira.awan@inova.org

    Jared Spitz, MD

    Not yet recruiting

  • Wellstar Kennestone Hospital

    Hiram, Georgia, 30141

    Frank Corrigan, MD, 678-324-4444, frank.corrigan@wellstar.org

    Frank Corrigan, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Peyton Martin, 443-413-6350, knasir@houstonmethodist.org

    Khurrrram Nasir, MD

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Lynae Edmunds, 310--210-9806, laedmunds@mednet.ucla.edu

    Karol Watson, MD

    Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Los Angeles, California, 90502

    Sajad Hamal, 310-974-9336, shamal@lundquist.org

    Matthew Budoff, MD

    Recruiting

  • Marshfield Clinical Research Institute

    Marshfield, Wisconsin, 54449

    Kelly Scheffen, 715-221-7285, preempt@marshfieldresearch.org

    Jeff VanWormer

    Recruiting

  • Cardiology Associates

    Mobile, Alabama, 36608

    Lynn Ward, RN BSN CCRC, 251-607-9797, lynnward@cardassoc.com

    Jason Cole, MD

    Recruiting

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Dina Katz, MD, 914-762-5810, PRE-EMPT@northwell.edu

    Dina Katz, MD

    Not yet recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37203

    Gabriella Davies Thoppil, MD MPH, 615-421-1143, g.thoppil@vumc.org

    Deepak Gupta, MD

    Not yet recruiting

  • New York University Langone

    New York, New York, 10016

    Harmony Reynolds, MD, 212-263-4320, PREEMPT@nyulangone.org

    Harmony Reynolds, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Dolores Reynolds, RN, 212-746-4617, dtr2001@med.cornell.edu

    Sam Kim, MD

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Caroline Freeman, BS, 215-792-3872, Caroline.Freeman@Jefferson.edu

    Chris Chambers, MD

    Not yet recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Karli Drewencki, 412-647-2931, drewenckikr2@upmc.edu

    Anum Saeed, MD

    Not yet recruiting

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

    John Halvorson, 503-418-1679, halvorsj@ohsu.edu

    Maros Ferencik, MD

    Not yet recruiting

  • Wake Forest University, Advocate Health

    Winston-Salem, North Carolina, 27157

    Sophia Dawson, BA, 336-713-2338, Sophia.Dawson@advocatehealth.org

    Michael Shapiro, MD

    Recruiting

Other trials in United States

About this study

Official title: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

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:

Read more
  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.
  1. 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.

Read the detailed description

The PRE-EMPT trial will be a 2x2 factorial, double-masked, placebo-controlled randomized trial of the effects of high-intensity statin and low-dose colchicine, alone and in combination, on CCTA-defined Non-Calcified Coronary Plaque (NCCP) volume at 2 years. Participants found through the screening study with CAC 1-99, or through the known plaque pathway, will be eligible for the trial if they have NCCP without severe stenosis or any other exclusion criteria. Study drug will be delivered directly to participants' homes, lab samples will be self-collected at home, and all study visits will be virtual except the imaging visits (up to 3 over 2 years). The only in-person study activities will be the CAC scan, if applicable, and CCTA at baseline and 2 years. The investigators anticipate that this approach will be attractive to middle-aged, busy individuals who are otherwise healthy and asymptomatic. Importantly, all participants in PRE-EMPT will receive an mHealth lifestyle intervention designed to support behavioral modification, ensuring that all individuals benefit from evidence-based strategies for cardiovascular risk reduction.

Being tested
Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, Placebo
Keywords
Prevention, Heart Disease Prevention, Family History of Heart Disease, At risk for heart disease, coronary artery calcium, non-calcified coronary plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin 20 Mg Oral TabletDrug

    Also called Crestor

    Statin

  • Colchicine 0.5 MG Oral Tablet Once DailyDrug

    Also called Lodoco

    Anti-inflammatory

  • PlaceboDrug

    Placebo, non-active, drug-matched

Study groups in NCT07232069
Study groupRoleWhat they receive
rosuvastatin 20mg plus colchicine-matched placeboExperimentalstatin plus placebo (two pills once daily)
Receives: Drug: Rosuvastatin 20 Mg Oral Tablet; Drug: Placebo
colchicine 0.5mg plus rosuvastatin-matched placeboExperimentalanti-inflammatory plus placebo (two pills once daily)
Receives: Drug: Colchicine 0.5 MG Oral Tablet Once Daily; Drug: Placebo
rosuvastatin 20mg plus colchicine 0.5mgExperimentalstatin plus anti-inflammatory (two pills once daily)
Receives: Drug: Rosuvastatin 20 Mg Oral Tablet; Drug: Colchicine 0.5 MG Oral Tablet Once Daily
placebo plus placeboPlacebo comparatorPlacebo and placebo (two pills once daily)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.

    Plaque volume in mm3 in each group

    Measured: 2 years

Secondary outcomes (12)

  1. Number of participants with Drug Discontinuation

    Drug Tolerability outcome

    Measured: Up to 2 years

  2. Overall drug treatment adherence

    Number of days on study drugs

    Measured: Up to 2 years

  3. Safety events of special interest

    Number of safety events of special interest per group

    Measured: Up to 2 years

  4. Total plaque volume

    Plaque volume in mm3 per group

    Measured: Up to 2 years

  5. Low-attenuation plaque volume

    Low attenuated plaque volume in mm3 per group

    Measured: Up to 2 years

  6. Calcified plaque volume

    Calcified plaque volume in mm3 per group

    Measured: Up to 2 years

  7. Number of participants with stenosis

    Number of participants with stenosis per group

    Measured: Up to 2 years

  8. Segment involvement score

    Average score per group

    Measured: Up to 2 years

  9. Number of participants with qualitative calcified, partially calcified and non-calcified plaque composition

    Number of participants with each plaque composition description per group

    Measured: Up to 2 years

  10. Number of participants with High-risk plaque features (positive remodeling, spotty calcium, napkin ring sign)

    Number of participants with each plaque feature (high-risk) per group

    Measured: Up to 2 years

  11. Change in LDL-C (low-density lipoprotein cholesterol)

    Measured: Baseline to 2 years

  12. Change in non-HDL-C (high-density lipoprotein cholesterol)

    Measured: Baseline to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start21 Jul 2026
  3. Primary completionJul 2031 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232069
Sponsor's protocol ID
Pro00118744
Other IDs
UG3HL181434
Acronym
PRE-EMPT
Status last verified
Jul 2026
First submitted
14 Nov 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin 20 Mg Oral Tablet and Colchicine 0.5 MG Oral Tablet Once Daily in people with Coronary Artery Disease Risk Factors Multiple and Coronary Artery Disease Progression, run by Duke University at 23 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Olson, Project Manager (919-309-5544, rachel.e.olson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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