PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
Public ClinicalTrials.gov record NCT07232069. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07232069
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,500 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 30 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 20, 2026
- Primary completion
- Jun 30, 2031
- Completion
- Jun 30, 2031
- Last update posted
- Aug 31, 2026
2026 – 2031
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | Recruiting |
| Cardiology Associates | Mobile | Alabama | 36608 | Recruiting |
| University of California, Los Angeles | Los Angeles | California | 90095 | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Los Angeles | California | 90502 | Recruiting |
| Wellstar Kennestone Hospital | Hiram | Georgia | 30141 | Recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Not yet recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21287 | Not yet recruiting |
| Massachusetts General Hospital Brigham | Boston | Massachusetts | 02114 | Not yet recruiting |
| Essentia Health | Duluth | Minnesota | 55805 | Not yet recruiting |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | Not yet recruiting |
| New York University Langone | New York | New York | 10016 | Not yet recruiting |
| Weill Cornell Medicine | New York | New York | 10021 | Recruiting |
| Duke University Hospital | Durham | North Carolina | 27710 | Recruiting |
| Wake Forest University, Advocate Health | Winston-Salem | North Carolina | 27157 | Not yet recruiting |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | Not yet recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Not yet recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Not yet recruiting |
| Vanderbilt University | Nashville | Tennessee | 37203 | Not yet recruiting |
| Houston Methodist Hospital | Houston | Texas | 77030 | Not yet recruiting |
| University of Virginia (UVA) | Charlottesville | Virginia | 22903 | Not yet recruiting |
| Inova Health System | Fairfax | Virginia | 22031 | Not yet recruiting |
| Marshfield Clinical Research Institute | Marshfield | Wisconsin | 54449 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07232069, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 31, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07232069 live on ClinicalTrials.gov.