The Prevent Coronary Artery Disease Trial

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06494501
Phase
PHASE3
Status
Recruiting
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Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
ALL
Age
30 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran — DRUG
    Subjects will be administered a single subcutaneous injection of 284 mg inclisiran for injection at predefined time points.

Study Details

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.

Key Dates

Start date
Sep 12, 2024
Status verified
Apr 2025
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Inclisiran
    Participants in this arm will receive the study drug (inclisiran, for 5 years). Specific measures will be implemented to achieve the following goals: LDL-C \<55 mg/dl; blood pressure \<130/80 mmHg; and HbA1c \<6.5%. Diet and lifestyle recommendations will be recommended to all patients as a first step. Follow-up will occur every 2 months until goals are achieved. If the goal is not achieved, the subsequent recommendation will be implemented. Pharmacologic treatment may be implemented as early as the first visit at the discretion of the physician. * Product Name: inclisiran * Active ingredient: inclisiran sodium * Dosage Form: Solution for Injection * Unit Dose Inclisiran sodium 300 mg/1.5 mL vial (equivalent to 284 mg inclisiran) * Route of Administration: SC use * Physical Description: Clear, colorless to pale yellow solution essentially free of particulates
  • No Intervention: Control Group
    Participants in this group will receive guideline directed medical treatment, according to American Heart Association/American College of Cardiology guidelines. These recommendations will be provided to the primary care physicians to be followed, according to standards of care. Follow-up visits will occur every 6 months, although patients might be seen more often according to their provider´s criteria.

Primary Outcome Measure

Change in atherosclerotic plaque burden from baseline [ Time Frame: Baseline, 2.5 years and 5 years after randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Fuster Heart HospitalNew YorkNew York10029
Valentin Fuster, MD
212-241-7911
Valentin Fuster, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Fuster Heart Hospital· New York, NY

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