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The Prevent Coronary Artery Disease Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Prevent Coronary Artery Disease Trial

Quick Facts

Study Start:2024-07

Study Completion:2032-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06494501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. * 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	* 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.

Inclusion Criteria

Exclusion 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.
* 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

* 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.

Contacts and Locations

Study Contact

Malick Waqas

CONTACT

646-939-7532

precadteam@mountsinai.org

Principal Investigator

Valentin Fuster, MD, PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Fuster Heart Hospital

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07

Study Completion Date2032-06-30

Study Record Updates

Study Start Date2024-07

Study Completion Date2032-06-30

Terms related to this study

Additional Relevant MeSH Terms

Atherosclerotic Cardiovascular Disease