Status:
RECRUITING
The Prevent Coronary Artery Disease Trial
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
30-50 years
Phase:
PHASE3
Brief 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 cardiov...
Detailed 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 maintaini...
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.
- The presence of atherosclerotic plaque by 3DVUS will be defined according to the PESA study definitions14: plaque is defined as a focal protrusion into the arterial lumen of thickness \>0.5 mm or \>50% if the intima media thickness or intima media thickness \>1.5 mm. CT scan for coronary artery calcium assessment will not be part of the protocol but will be used where available.
- Risk enhancers are defined as15:
- 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
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator's \[or delegate\] judgment) if he/she participates in the clinical study.
- 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.
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT06494501
Start Date
September 12 2024
End Date
June 30 2032
Last Update
April 29 2025
Active Locations (1)
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1
Mount Sinai Fuster Heart Hospital
New York, New York, United States, 10029