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NCT01837823 · ClinicalTrials.gov registry record · Phase 2
YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT01837823 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 91 participants.
The verdict
NCT01837823, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well known that the reduction of cholesterol levels by statin therapy is associated with significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II trial showed that in patients with CAD, lipid lowering with atorvastatin or rosuvastatin respectively reduced progression of coronary atherosclerosis, even causing plaque regression of some lesions. CAD clinical events are related to plaque instability due to lipid content and activity within the atherosclerotic plaque. The investigators recently completed the YELLOW I study, and identified that intensive statin therapy (rosuvastatin 40mg) was associated with a reduction in the amount of lipid in obstructive coronary plaques, as measured by near-infrared spectroscopy (NIRS). The YELLOW II study is designed to expand and build upon these results, and to provide mechanistic insights into the potential benefits of intensive statin therapy on atherosclerotic plaques.
Interventions
- DRUG rosuvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01837823
The ClinicalTrials.gov registry entry for NCT01837823 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which rosuvastatin is the first listed.
NCT01837823 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01837823 about?
NCT01837823 is a clinical study titled "YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering". Coronary artery disease (CAD) remains a leading cause of death in most countries. It is well known that the reduction of cholesterol levels by statin therapy is associated with significant decreases in plaque burden. REVERSAL, ASTEROID, and more recently the SATURN II trial showed that in patients w...
What is the current status of trial NCT01837823?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2013-07. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01837823?
The interventions under investigation include: rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT01837823?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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