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NCT06494501 · ClinicalTrials.gov registry record · Phase 3
The Prevent Coronary Artery Disease Trial
A Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,600
- Enrollment target
- 1
- Study location
NCT06494501: Recruiting Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06494501 is a Phase 3 study of Atherosclerotic Cardiovascular Disease that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 1,600 participants, below the 7,492-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06494501, a Phase 3 study of Atherosclerotic Cardiovascular Disease, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,600 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Inclisiran
Study Locations (1)
New York
- Mount Sinai Fuster Heart Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2024-09-12 |
| Est. Completion | 2032-06-30 |
| Phase | Phase 3 |
What NCT06494501 shows while recruiting
NCT06494501 is an interventional study that assigns participants to a tested intervention. Its 1,600 participants enrollment target places it among the larger protocols in the corpus, below the 7,492-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Inclisiran is the first listed.
NCT06494501 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06494501 about?
NCT06494501 is a clinical study titled "The Prevent Coronary Artery Disease Trial". 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 preven...
What is the current status of trial NCT06494501?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,600 participants. The study started on 2024-09-12. Estimated completion is 2032-06-30.
What conditions does trial NCT06494501 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT06494501?
The interventions under investigation include: Inclisiran (DRUG).
Who is sponsoring clinical trial NCT06494501?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06494501 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atherosclerotic Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06494501's enrollment target sits among peer trials
1,600 9th of 21 higher than 13 of 21 other Atherosclerotic Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerotic Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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