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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04710368
The ClinicalTrials.gov registry entry for NCT04710368 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (89% lower). The listed sponsor is Annapoorna Kini, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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