Actively Recruiting
The Prevent Coronary Artery Disease Trial
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-29
1600
Participants Needed
1
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Prevent Coronary Artery Disease Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 cholesterol above 70 mg/dL (1.8 mmol/l)
- Presence of subclinical atherosclerosis detected by 3D vascular ultrasound or coronary artery calcium score of 25 or higher, or high lifetime risk (30% or more) using ASCVD calculator, or intermediate 10-year risk (7.5% or more) with 2 risk enhancers
- Risk enhancers include family history of early cardiovascular disease, persistent LDL cholesterol 160 mg/dL or higher, chronic kidney disease, metabolic syndrome, certain conditions in women (e.g., preeclampsia, early menopause), inflammatory diseases (rheumatoid arthritis, psoriasis, HIV), South Asian ancestry, high triglycerides (175 mg/dL or higher), high hs-CRP (2 mg/L or higher), Lp(a) levels above 50 mg/dL, apoB 130 mg/dL or higher, or ankle-brachial index less than 0.9
You will not qualify if you...
- Any uncontrolled or serious disease or medical/surgical condition that could interfere with study participation or pose significant risk
- Known diseases or conditions that might affect interpretation of study results
- Female participants who are pregnant, nursing, or of childbearing potential unwilling to use two highly effective contraception methods during the study
- Severe non-cardiovascular diseases limiting life expectancy to less than 5 years
- History of cancer requiring surgery, radiation, or systemic therapy within 3 years prior to randomization
- Active liver disease or elevated liver enzymes beyond defined limits
- Known contraindications to anti-lipid therapy
- History of alcohol or drug abuse in the last 5 years
- Use of other investigational products or devices within 30 days or five half-lives before screening, or planned use during the study
- Conditions that prevent communication, cooperation, understanding, or compliance with the study protocol
- Treatment with monoclonal antibodies against PCSK9 within 90 days before screening
- Known allergy to the study drug or related siRNA drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Fuster Heart Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Malick Waqas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here