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

a study on Coronary Artery Disease Peripheral Artery Disease Prevention & Control Atherosclerosis

Summary

Eligibility
for people ages 30-60 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around
Principal Investigator
by Karol Watson, MDMatthew Budoff, MD
Headshot of Karol Watson
Karol Watson

Description

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.

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.

Official Title

Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis

Details

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.

Keywords

Coronary Artery Disease Risk Factors Multiple, Coronary Artery Disease Progression, Prevention & Control, Premature Atherosclerosis, Prevention, Heart Disease Prevention, Family History of Heart Disease, At risk for heart disease, coronary artery calcium, non-calcified coronary plaque, Rosuvastatin Calcium, Tablets, Colchicine, Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, rosuvastatin 20mg plus colchicine 0.5mg

Eligibility

You can join if…

Open to people ages 30-60

  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

You CAN'T join if...

  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

  • University of California, Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Los Angeles California 90502 United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham Alabama 35205 United States

Lead Scientists at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT07232069
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1500 study participants
Last Updated