The Prevent Coronary Artery Disease Trial (PRECAD)

This study, called PRECAD, is looking at whether early treatment can prevent heart disease in younger adults. It's testing a drug called inclisiran, given as a single injection, to see if it can reduce the amount of plaque (fatty deposits) in your arteries. You might be able to join if you are between 30 and 50 years old, have no history of heart disease, and have high LDL-C (bad cholesterol) levels (above 1.8 mmol/l or 70 mg/dl). You also need to show signs of early atherosclerosis (hardening of the arteries) through specific tests. The study aims to see if this treatment can slow down or stop the progression of atherosclerosis over 5 years. The current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 1600 participants. It is a randomized controlled trial comparing the study drug to usual care.
What's involved: You would receive a single subcutaneous injection of 284 mg inclisiran at specific times. Your atherosclerotic plaque burden will be measured at the beginning of the study, after 2.5 years, and again after 5 years.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 5 years after randomization to measure changes in atherosclerotic plaque burden.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The Prevent Coronary Artery Disease Trial

Recruiting

PHASE3Ages 30–50InterventionalPrevention

Icahn School of Medicine at Mount Sinai

~1,600 participants

Updated 2025-04-29 on ClinicalTrials.gov

What's tested:Inclisiran

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in atherosclerotic plaque burden from baseline

Measured over Baseline, 2.5 years and 5 years after randomization

Conditions

Atherosclerotic Cardiovascular Disease

Where it's being run

1 sites across 1 states

New York1

Study leadership

Valentin Fuster, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Malick Waqas

[email protected]

646-939-7532

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

Family history of premature atherosclerotic CVD

Persistently elevated LDL-C ≥ 160 mg/dl

Chronic kidney disease

Metabolic syndrome

Conditions specific to women (e.g. preeclampsia, premature menopause)

Inflammatory diseases (especially rheumatoid arthritis, psoriasis, HIV)

Ethnicity (e.g., South Asian ancestry)

Persistently elevated triglycerides (≥175 mg/dl)

Hs-CRP ≥2 mg/L

Lp(a) levels \>50 mg/dl

apoB ≥130 mg/dl

Ankle-brachial index \<0.9

Exclusion

An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.

Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception (failure rate less than 1% per year) (e.g. combined oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, or intrauterine device) for the entire duration of the study.

Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years.

History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization

Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in ALT, aspartate aminotransferase (AST), \>3x the ULN, or total bilirubin \>2x ULN at screening confirmed by a repeat abnormal measurement at least 1 week apart.

Known contraindications to anti-lipid therapy

Known history of alcohol and/or drug abuse within the last 5 years.

Treatment with other investigational products or devices within 30 days or five half- lives of the screening visit, whichever is longer.

Planned use of other investigational products or devices during the course of the study.

Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:

Subjects who are unable to communicate or to cooperate with the investigator.

Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency).

Unlikely to comply with the protocol requirements, instructions, and study- related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).

Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study.

Persons directly involved in the conduct of the study.

Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.

History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.

What this trial measures

Change in atherosclerotic plaque burden from baselineBaseline, 2.5 years and 5 years after randomization
Change in atherosclerotic plaque burden at 2.5 years and the last year of follow up from baseline as measured by the 3D vascular ultrasound. Atherosclerotic plaque burden is amount of plaque in the arteries.

Trialytics