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PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
Sponsor: Duke University
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
Key Details
Gender
All
Age Range
30 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2026-07-01
Completion Date
2031-07
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Rosuvastatin 20 Mg Oral Tablet
Statin
Colchicine 0.5 MG Oral Tablet Once Daily
Anti-inflammatory
Placebo
Placebo, non-active, drug-matched
Locations (23)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cardiology Associates
Mobile, Alabama, United States
University of California, Los Angeles
Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Los Angeles, California, United States
Wellstar Kennestone Hospital
Hiram, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital Brigham
Boston, Massachusetts, United States
Essentia Health
Duluth, Minnesota, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
New York University Langone
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest University, Advocate Health
Winston-Salem, North Carolina, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia (UVA)
Charlottesville, Virginia, United States
Inova Health System
Fairfax, Virginia, United States
Marshfield Clinical Research Institute
Marshfield, Wisconsin, United States