See if early heart plaque can be reduced with statin and colchicine in people at risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PRE-EMPT screens adults with low 10-year heart disease risk to find early plaque in the heart arteries. Participants may undergo CAC or CCTA imaging, then be randomized in a 2x2 design to receive rosuvastatin, colchicine, both, or placebo for two years. Treatments are delivered at home with most visits done remotely, and imaging visits occur at baseline and year two. All participants also receive a home-based lifestyle program to support cardiovascular risk reduction. The study aims to determine effects on non-calcified coronary plaque volume as measured by imaging.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Cardiology Associates
  Mobile, Alabama, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Wellstar Kennestone Hospital
  Hiram, Georgia, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Rachel Olson, Project Manager
• Email: rachel.e.olson@duke.edu
• Phone: 919-309-5544

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.