CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
standard of care lipid therapy +1 moredrug
Likely dose
standard of care lipid therapy 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01567826
NCT01567826Phase 4Completed

Reduction in YEllow Plaque by Aggressive Lipid LOWering Therapy. (YELLOW Trial)

Annapoorna Kini·interventional·Posted Mar 30, 2012·Updated May 19, 2017

In Brief

A Phase 4 clinical trial evaluating standard of care lipid therapy and Aggressive lipid therapy for Coronary Artery Disease. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2012
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago

Interventions

standard of care lipid therapydrug

Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy. Zocor, Lipitor \[any dose\] and Crestor \[less than 40mg\]

Aggressive lipid therapydrug

Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.