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

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.

Conditions

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

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Duke University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2031-07-31

Completion

2031-07-31

FDA Drug

Yes