The Prevent Coronary Artery Disease Trial

Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evidence to support primary prevention strategies in adults aged 30-50 years. The researchers have designed a randomized controlled trial to evaluate whether strict control of CVRF in young adults without known cardiovascular disease, will reduce the progression of total atherosclerosis burden, a surrogate endpoint for symptomatic cardiovascular disease, compared with usual care. The researchers propose a randomized controlled trial enrolling 1,600 healthy young adults who meet the inclusion criteria and who do not meet any exclusion criteria. Eligible study participants will be randomized, in a 1:1 ratio, to either the intervention group (active treatment strategy) or to the control group (guideline-directed medical therapy). Randomization will be stratified by the presence or absence of atherosclerotic plaque in vascular ultrasound.

NCT Number	NCT06494501
Lead Sponsor	Icahn School of Medicine at Mount Sinai
Conditions	Atherosclerotic Cardiovascular Disease
Enrollment	1,600 participants
Start Date	2024-09-12
Primary Completion	2032-06-30 (estimated)
Study Completion	2032-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-29