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Can a simple drug combo stop heart disease before it starts?

NCT ID NCT07232069

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 11 times

Summary

This study will screen 1,500 people with early signs of heart disease (plaque in arteries) to see if two common drugs—rosuvastatin and colchicine—can reduce or stabilize that plaque over two years. Participants will take pills daily and get heart-healthy lifestyle advice. The goal is to find out if early treatment can prevent heart disease from getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rosuvastatin (a cholesterol-lowering statin) and colchicine (an anti-inflammatory drug)
What this could lead to
If it works, this could show that early treatment with common drugs can slow or stabilize plaque buildup in heart arteries, potentially preventing future heart attacks.
What could go wrong
This is a large Phase 3 trial, but it's still testing an idea—early treatment may not work better than lifestyle advice alone. Side effects from the drugs, like muscle pain or stomach issues, could also limit their use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atherosclerosis coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease progression Coronary artery disease risk factors multiple Premature atherosclerosis Prevention & control

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiology Associates

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Essentia Health

    NOT_YET_RECRUITING

    Duluth, Minnesota, 55805, United States

  • Houston Methodist Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Inova Health System

    NOT_YET_RECRUITING

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins University

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90502, United States

  • Marshfield Clinical Research Institute

    NOT_YET_RECRUITING

    Marshfield, Wisconsin, 54449, United States

  • Massachusetts General Hospital Brigham

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina (MUSC)

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • New York University Langone

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Northern Westchester Hospital

    NOT_YET_RECRUITING

    Mount Kisco, New York, 10549, United States

  • Oregon Health and Sciences University

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Thomas Jefferson University

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Pittsburgh Medical Center

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia (UVA)

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

  • Wake Forest University, Advocate Health

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • Wellstar Kennestone Hospital

    RECRUITING

    Hiram, Georgia, 30141, United States

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