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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06494501
The ClinicalTrials.gov registry entry for NCT06494501 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,492-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (79% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.