The Prevent Coronary Artery Disease Trial
Icahn School of Medicine at Mount Sinai
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.
Description
Atherosclerotic cardiovascular disease (ASCVD) is the most common cause of death in the world and contributes importantly to the majority of the world's deaths. Substantial data suggest that maintaining optimal population serum low density lipoprotein cholesterol (LDL-C), starting early in life, has the potential to lower the risk of incident ASCVD. However, this strategy of early initiation of LDL-C lowering therapies would represent a major paradigm shift from current guideline-based practice. Widespread acceptance and implementation of this approach in the medical community necessary to gai…
Eligibility
- Age range
- 30–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female subjects between 30 to 50 years of age. * No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease. * Serum LDL-C \> 1.8 mmol/l (70 mg/dl). * Presence of subclinical atherosclerosis as assessed by 3DVUS or by the presence of coronary artery calcium (defined as coronary artery calcium score ≥25), independent of risk calculators; and/or high lifetime risk (≥30%) using the ASCVD calculator; and/or intermediate 10-year risk (≥7.5%) using the ASCVD calculator in the presence of 2 risk enhancers. The presence of atherosc…
Interventions
- DrugInclisiran
Subjects will be administered a single subcutaneous injection of 284 mg inclisiran for injection at predefined time points.
Location
- Mount Sinai Fuster Heart HospitalNew York, New York