What is this study trying to find out about premature atherosclerosis?

This study is evaluating if screening and early treatment with statin and colchicine medications can reduce or stabilize early plaque buildup in heart arteries. The trial aims to understand how these medications affect plaque volume over two years in adults at risk for heart disease.

Who may be eligible for this premature atherosclerosis clinical trial?

Adults between 30 and 60 years old with specific heart disease risk factors may be eligible. Participants must be able to use a smartphone and not have clinical atherosclerotic cardiovascular disease or certain other health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this premature atherosclerosis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and related costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 30Years - 60Years

All Genders

ID07232069

PRE-EMPT Study Screening and Early Treatment Using Statin and Colchicine for Adults at Risk of Premature Atherosclerosis and Heart Disease

Led by Duke University · Updated on 2026-08-11

1500

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Heart disease is a leading cause of death across many groups in the United States. Researchers are evaluating if screening and early treatment of mild heart disease can improve outcomes. This trial focuses on adults at low 10-year heart disease risk who have risk factors, aiming to detect early plaque buildup in heart arteries using specialized CT scans. The study includes two parts a screening phase using Coronary Artery Calcium CAC scans and Coronary CT Angiography CCTA to identify plaque, followed by a treatment trial for about 1,500 participants. Those with certain plaque levels may be randomly assigned to receive either placebo or medicationsrosuvastatin a cholesterol-lowering drug and colchicine an anti-inflammatory drugin various combinations taken once daily. Participants also receive advice on heart-healthy lifestyle changes and an mHealth program to support behavior modification. Participants undergo up to two in-person visits during screening and several virtual visits during the treatment phase over two years, including blood collection at home and CCTA scans at baseline and study end. The main goal is to measure changes in non-calcified plaque volume in arteries over two years. Safety, treatment adherence, and various plaque-related outcomes will also be monitored throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

Women aged 40 to 60 years; men aged 30 to 50 years
Willing and able to provide informed consent and comply with study procedures
Must be a smartphone user
Women with reproductive potential must use highly effective contraception
Coronary artery calcium (CAC) score between 1 and 99 in the screening study or eligibility through known plaque pathway
Baseline Coronary CT Angiography (CCTA) showing non-calcified plaque volume of at least 10 mm3

You will not qualify if you...

Clinical diagnosis of atherosclerotic cardiovascular disease, including coronary artery disease, peripheral arterial disease, or cerebrovascular disease
Current symptoms believed to be caused by coronary artery disease
PREVENT ASCVD 10-year risk of 5% or higher
Diabetes mellitus diagnosis or hemoglobin A1c of 6.5% or greater
LDL cholesterol level of 190 mg/dL or higher
HIV infection
Severe liver disease or untreated hepatitis C infection
Pregnancy, breastfeeding, or intending to become pregnant during the 2-year study
Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73m2
Elevated liver enzymes (AST or ALT more than 1.5 times upper limit)
Body mass index over 40 kg/m2 or inability to undergo CCTA scan
Allergy to iodinated intravenous contrast or contraindication to CCTA
Current or previous use of lipid-lowering therapy or colchicine
Known allergies or intolerance to study medications or contraindicated long-term medications
Active systemic cancer treatment
Severe proximal coronary artery stenosis (50% or more in left main or 70% or more in major coronary arteries)
Contraindication to follow-up CCTA imaging

Research Team

Rachel Olson, Project Manager

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PRE-EMPT Study Screening and Early Treatment Using Statin and Colchicine for Adults at Risk of Premature Atherosclerosis and Heart Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria