RecruitingPhase 3NCT06494501

The Prevent Coronary Artery Disease Trial


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

1,600 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inclisiran for people with atherosclerotic cardiovascular disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInclisiran

Subjects will be administered a single subcutaneous injection of 284 mg inclisiran for injection at predefined time points.


Locations(1)

Mount Sinai Fuster Heart Hospital

New York, New York, United States

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NCT06494501


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