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NCT07232069 · ClinicalTrials.gov registry record · Phase 3
PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
A Phase 3 study, sponsored by Duke University.
- Not yet
- Registry status
- Phase 3
- Development phase
- 1,500
- Enrollment target
NCT07232069 is a Phase 3 study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 1,500 participants.
The verdict
NCT07232069, a Phase 3 study, has not yet begun recruiting, sponsored by Duke University.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,500 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Rosuvastatin 20 Mg Oral Tablet
- DRUG Colchicine 0.5 MG Oral Tablet Once Daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2031-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07232069
The ClinicalTrials.gov registry entry for NCT07232069 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07232069 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07232069 about?
NCT07232069 is a clinical study titled "PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis". 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 ...
What is the current status of trial NCT07232069?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 1,500 participants. The study started on 2026-07-01. Estimated completion is 2031-07.
What interventions are being tested in trial NCT07232069?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin 20 Mg Oral Tablet (DRUG), Colchicine 0.5 MG Oral Tablet Once Daily (DRUG).
Who is sponsoring clinical trial NCT07232069?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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