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NCT01567826 · ClinicalTrials.gov registry record · Phase 4
Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy
A Phase 4 study of Coronary Artery Disease, sponsored by Annapoorna Kini.
- Completed
- Registry status
- Phase 4
- Development phase
- 87
- Enrollment target
- 1
- Study location
NCT01567826: Completed Phase 4 study of Coronary Artery Disease, sponsored by Annapoorna Kini.
NCT01567826 is a Phase 4 study of Coronary Artery Disease that has completed, run by Annapoorna Kini. The registered enrollment target is 87 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01567826, a Phase 4 study of Coronary Artery Disease, has completed, sponsored by Annapoorna Kini.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 87 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will assess the regression of yellow plaque content of the lipid pool after aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin 10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This is a single site study. A total of 100 subjects will randomized, of which 40 will receive intensive lipid therapy (Rosuvastatin 40mg) and 40 will receive standard care lipid lowering therapy.
Primary Outcome
The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as
Conditions Studied
Interventions
- DRUG standard of care lipid therapy
- DRUG Aggressive lipid therapy
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01567826 record still lists
NCT01567826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which standard of care lipid therapy is the first listed.
NCT01567826 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01567826 about?
NCT01567826 is a clinical study titled "Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy". The study will assess the regression of yellow plaque content of the lipid pool after aggressive lipid therapy by utilizing NIR spectroscopy. Statin therapy using Rosuvastatin 10-40 mg will be compared to the statin therapy of either Atorvastatin or Simvastatin. This is a single site study. A total ...
What is the current status of trial NCT01567826?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 87 participants. The study started on 2010-05. Estimated completion is 2012-02.
What conditions does trial NCT01567826 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01567826?
The interventions under investigation include: standard of care lipid therapy (DRUG), Aggressive lipid therapy (DRUG).
Who is sponsoring clinical trial NCT01567826?
This trial is sponsored by Annapoorna Kini, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01567826 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 Coronary Artery 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 NCT01567826's enrollment target sits among peer trials
87 156th of 219 higher than 63 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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