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

RecruitingPhase 3Ages 30 Years - 60 YearsAllDuke University
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In plain words

What the trial is, and whether it could suit you

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, partic

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Rosuvastatin 20 Mg Oral Tablet
  • Colchicine 0.5 MG Oral Tablet Once Daily
  • Placebo
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Where

23 sites
University of Alabama at Birmingham
Birmingham, United States
Cardiology Associates
Mobile, United States
University of California, Los Angeles
Los Angeles, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Los Angeles, United States
Wellstar Kennestone Hospital
Hiram, United States
University of Chicago
Chicago, United States
Johns Hopkins University
Baltimore, United States
Massachusetts General Hospital Brigham
Boston, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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