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

NCT07232069 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: Pro00118744UG3HL181434
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease Progression; Prevention & Control; Premature Atherosclerosis; Coronary Artery Disease Risk Factors Multiple

Keywords

Prevention; Heart Disease Prevention; Family History of Heart Disease; At risk for heart disease; coronary artery calcium; non-calcified coronary plaque

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

Study Arms (4)

rosuvastatin 20mg plus colchicine-matched placebo

EXPERIMENTAL

statin plus placebo (two pills once daily)

Drug: Rosuvastatin 20 Mg Oral Tablet; Drug: Placebo

colchicine 0.5mg plus rosuvastatin-matched placebo

EXPERIMENTAL

anti-inflammatory plus placebo (two pills once daily)

Drug: Colchicine 0.5 MG Oral Tablet Once Daily; Drug: Placebo

rosuvastatin 20mg plus colchicine 0.5mg

EXPERIMENTAL

statin plus anti-inflammatory (two pills once daily)

Drug: Rosuvastatin 20 Mg Oral Tablet; Drug: Colchicine 0.5 MG Oral Tablet Once Daily

placebo plus placebo

PLACEBO COMPARATOR

Placebo and placebo (two pills once daily)

Drug: Placebo

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily DRUG

Anti-inflammatory

Also known as: Lodoco

colchicine 0.5mg plus rosuvastatin-matched placebo; rosuvastatin 20mg plus colchicine 0.5mg

Rosuvastatin 20 Mg Oral Tablet DRUG

Statin

Also known as: Crestor

rosuvastatin 20mg plus colchicine 0.5mg; rosuvastatin 20mg plus colchicine-matched placebo

Placebo DRUG

Placebo, non-active, drug-matched

colchicine 0.5mg plus rosuvastatin-matched placebo; placebo plus placebo; rosuvastatin 20mg plus colchicine-matched placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Women aged 40-60 years old, Men aged 30-50 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: collaborator
• Massachusetts General Hospital: collaborator
• Johns Hopkins University: collaborator
• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Interventions

Rosuvastatin Calcium; Tablets; Colchicine

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Alkaloids

Central Study Contacts

PRE-EMPT Email

CONTACT

919-309-5544; PREEMPT@duke.edu

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 (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share