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

NCT07232069

RecruitingPhase 3

Sponsor: Duke University

Conditions: Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression, Prevention & Control, Premature Atherosclerosis

Interventions: Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (23)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Hiram, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Duluth, Minnesota, United States
Mount Kisco, New York, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Marshfield, Wisconsin, United States