Condition: Coronary Artery Disease Risk Factors Multiple · Coronary Artery Disease Progression · Prevention & Control · Sponsor: Duke University
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 hav…
This description comes directly from the study's public registry record.
Rachel Olson, Project Manager · 919-309-5544 · rachel.e.olson@duke.edu
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| Cardiology Associates | Mobile, Alabama, United States | Not Yet Recruiting |
| University of California, Los Angeles | Los Angeles, California, United States | Not Yet Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Los Angeles, California, United States | Recruiting |
| Wellstar Kennestone Hospital | Hiram, Georgia, United States | Not Yet Recruiting |
| University of Chicago | Chicago, Illinois, United States | Not Yet Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Not Yet Recruiting |
| Massachusetts General Hospital Brigham | Boston, Massachusetts, United States | Not Yet Recruiting |
| Essentia Health | Duluth, Minnesota, United States | Not Yet Recruiting |
| Northern Westchester Hospital | Mount Kisco, New York, United States | Not Yet Recruiting |
| New York University Langone | New York, New York, United States | Not Yet Recruiting |
| Weill Cornell Medicine | New York, New York, United States | Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07232069