PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
PRE-EMPT
Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis
2 other identifiers
interventional
1,500
1 country
23
Brief 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:
- 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2026
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
July 28, 2026
July 1, 2026
5 years
November 14, 2025
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.
Plaque volume in mm3 in each group
2 years
Secondary Outcomes (12)
Number of participants with Drug Discontinuation
Up to 2 years
Overall drug treatment adherence
Up to 2 years
Safety events of special interest
Up to 2 years
Total plaque volume
Up to 2 years
Low-attenuation plaque volume
Up to 2 years
- +7 more secondary outcomes
Study Arms (4)
rosuvastatin 20mg plus colchicine-matched placebo
EXPERIMENTALstatin plus placebo (two pills once daily)
colchicine 0.5mg plus rosuvastatin-matched placebo
EXPERIMENTALanti-inflammatory plus placebo (two pills once daily)
rosuvastatin 20mg plus colchicine 0.5mg
EXPERIMENTALstatin plus anti-inflammatory (two pills once daily)
placebo plus placebo
PLACEBO COMPARATORPlacebo and placebo (two pills once daily)
Interventions
Anti-inflammatory
Statin
Placebo, non-active, drug-matched
Eligibility Criteria
You may qualify if:
- Women aged 40-60 years; Men aged 30-50 years
- Willing and able to provide informed consent and comply with study procedures
- Smart phone user
- Use of highly effective contraception by females with reproductive potential.
- Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab
You may not qualify if:
- Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)
- Current symptoms thought to be from CAD
- PREVENT ASCVD 10-year risk ≥5% (if known)
- Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)
- LDL-C ≥190mg/dL (most recent, if known)
- HIV (if known)
- Severe liver disease or untreated Hepatitis C infection (if known)
- Pregnancy, lactation or intending to become pregnant during the study period of 2 years
- eGFR \<45mL/min/1.73m2 (if known)
- AST or ALT \>1.5x the upper limit of normal (if known)
- BMI\>40kg/m2 or unable to have a CCTA scan for any reason
- Allergy to iodinated intravenous contrast or other contraindication to CCTA
- Current or previous use of lipid lowering therapy or colchicine
- Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.
- Systemic cancer undergoing active treatment
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hillcollaborator
- Duke Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Massachusetts General Hospitalcollaborator
- Johns Hopkins Universitycollaborator
Study Sites (23)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Cardiology Associates
Mobile, Alabama, 36608, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Los Angeles, California, 90502, United States
Wellstar Kennestone Hospital
Hiram, Georgia, 30141, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital Brigham
Boston, Massachusetts, 02114, United States
Essentia Health
Duluth, Minnesota, 55805, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
New York University Langone
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest University, Advocate Health
Winston-Salem, North Carolina, 27157, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37203, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia (UVA)
Charlottesville, Virginia, 22903, United States
Inova Health System
Fairfax, Virginia, 22031, United States
Marshfield Clinical Research Institute
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
July 1, 2026
Primary Completion (Estimated)
July 1, 2031
Study Completion (Estimated)
July 1, 2031
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share