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NCT04710368 · ClinicalTrials.gov registry record · Phase 4
Effect of Evolocumab on Coronary Plaque Characteristics
A Phase 4 study of Coronary Artery Disease, sponsored by Annapoorna Kini.
- Completed
- Registry status
- Phase 4
- Development phase
- 137
- Enrollment target
- 1
- Study location
NCT04710368: Completed Phase 4 study of Coronary Artery Disease, sponsored by Annapoorna Kini.
NCT04710368 is a Phase 4 study of Coronary Artery Disease that has completed, run by Annapoorna Kini. The registered enrollment target is 137 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04710368, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by Annapoorna Kini.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 137 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy (NIRS) after 26 weeks of evolocumab. The secondary endpoints are the changes in (1) the maximal lipid arc, lipid length, lipid volume index, macrophage accumulation and calcification by OCT; (2) PAV and TAV defined by intravascular ultrasound (IVUS) and (3) Changes in PBMC gene expression.
Primary Outcome
Changes in the minimal Minimal Fibrous Cap Thickness (FCT) is assessed by Optical Coherence Tomography (OCT) imaging and measured in microns. FCT describes plaque morphology composition.
Conditions Studied
Interventions
- DRUG Evolocumab Injections
Study Locations (1)
New York
- Mount Sinai Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2023-11-06 |
| Phase | Phase 4 |
What the finished NCT04710368 record still lists
NCT04710368 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Evolocumab Injections is the first listed.
NCT04710368 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04710368 about?
NCT04710368 is a clinical study titled "Effect of Evolocumab on Coronary Plaque Characteristics". The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravas...
What is the current status of trial NCT04710368?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 137 participants. The study started on 2021-05-04. Estimated completion is 2023-11-06.
What conditions does trial NCT04710368 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT04710368?
The interventions under investigation include: Evolocumab Injections (DRUG).
Who is sponsoring clinical trial NCT04710368?
This trial is sponsored by Annapoorna Kini, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04710368 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
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Where NCT04710368's enrollment target sits among peer trials
137 135th of 219 higher than 85 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery 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.
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