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NOT YET RECRUITING
NCT07232069
PHASE3

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

Interventions

DRUG

Rosuvastatin 20 Mg Oral Tablet

Statin

DRUG

Colchicine 0.5 MG Oral Tablet Once Daily

Anti-inflammatory

DRUG

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