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 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.
Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.
Trial details
- acronym
- PRECAD
- status
- RECRUITING
- phase
- PHASE3
- study type
- INTERVENTIONAL
- enrollment
- 1600
- sponsor
- Icahn School of Medicine at Mount Sinai
- conditions
- Atherosclerotic Cardiovascular Disease
- interventions
- DRUG: Inclisiran
- start date
- 2024-09-12
- start date type
- ACTUAL
- primary completion date
- 2032-06-30
- has results
- false
- data source
- ClinicalTrials.gov
- data processed
- 2026-10-29T09:00:05
- modifications
- selected fields only; whitespace normalized; brief summary truncated to 2,000 characters
Record
- Archive ID
- nct:NCT06494501
- Published
- Jul 10, 2024
- Updated
- Apr 29, 2025
- Venue
- ClinicalTrials.gov
- ClinicalTrials.gov
- NCT06494501
- Categories
- Atherosclerotic Cardiovascular Disease
- License
- ClinicalTrials.gov terms (attribution, processing date, modifications noted)
- Provenance
- clinicaltrials
