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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567826
First Posted: March 30, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai
Results First Submitted: May 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: standard of care lipid therapy
Drug: Aggressive lipid therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
779 patients consecutive patients with chronic stable angina presenting for elective coronary angiography were screened from May 21, 2010 until Jan 10, 2012. 87 participants met criteria and were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard of Care Lipid Therapy

standard-care lipid-lowering therapy: Zocor or Lipitor

standard of care lipid therapy: 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 Therapy

aggressive lipid therapy: Crestor

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


Participant Flow:   Overall Study
    Standard of Care Lipid Therapy   Aggressive Lipid Therapy
STARTED   43   44 
COMPLETED   40   42 
NOT COMPLETED   3   2 
Lost to Follow-up                3                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard of Care Lipid Therapy

standard-care lipid-lowering therapy: Zocor or Lipitor

standard of care lipid therapy: 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 Therapy

aggressive lipid therapy: Crestor

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

Total Total of all reporting groups

Baseline Measures
   Standard of Care Lipid Therapy   Aggressive Lipid Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   44   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (9.8)   64.4  (9.29)   63.6  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  27.9%      9  20.5%      21  24.1% 
Male      31  72.1%      35  79.5%      66  75.9% 
Current tobacco use 
[Units: Participants]
     
yes   4   9   13 
no   39   35   74 
Hypertension 
[Units: Participants]
     
yes   40   40   80 
no   3   4   7 
Hypercholesterolemia 
[Units: Participants]
     
yes   40   39   79 
no   3   5   8 
Diabetes mellitus [1] 
[Units: Participants]
     
yes   3   5   8 
no   40   39   79 
[1] (treated with insulin)
Prior CVA/TIA [1] 
[Units: Participants]
     
yes   3   2   5 
no   40   42   82 
[1] Cerebrovascular accident (CVA); Transient ischemic attack (TIA)
Previous MI [1] 
[Units: Participants]
     
yes   8   8   16 
no   35   36   71 
[1] Myocardial infarction (MI)
Previous PCI [1] 
[Units: Participants]
     
yes   20   16   36 
no   23   28   51 
[1] Percutaneous coronary intervention (PCI)
Statin Use 
[Units: Participants]
     
yes   35   37   72 
no   8   7   15 
Beta-blocker use 
[Units: Participants]
     
yes   30   33   63 
no   13   11   24 
ACE-I/ARB use [1] 
[Units: Participants]
     
yes   19   16   35 
no   24   28   52 
[1] Angiotensin-converting enzyme inhibitor (ACE-I); Angiotensin receptor blocker (ARB)
Creatinine 
[Units: Mg/dl]
Mean (Standard Deviation)
 1.1  (1.3)   1.0  (0.3)   1.04  (0.96) 
LAD Coronary vessel [1] 
[Units: Participants]
     
yes   17   20   37 
no   26   24   50 
[1] Left anterior descending (LAD)
LCx coronary vessel [1] 
[Units: Participants]
     
yes   14   14   28 
no   29   30   59 
[1] Left circumflex (LCx)
RCA coronary vessel [1] 
[Units: Participants]
     
yes   13   10   23 
no   30   34   64 
[1] Right coronary artery (RCA)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lipiscan - Lipid Core Burden Index (LCBI)   [ Time Frame: at baseline and at 6-8 weeks after intervention ]

2.  Primary:   LCBI4mm Max   [ Time Frame: at baseline and at 6-8 weeks after intervention ]

3.  Primary:   Change in LCBI4mm Max   [ Time Frame: at baseline and at 6-8 weeks after intervention ]

4.  Primary:   Change in LCBI, Lesion   [ Time Frame: at baseline and at 6-8 weeks post intervention ]

5.  Secondary:   Intravascular Ultrasound (IVUS) Parameters   [ Time Frame: at baseline and at 6-8 weeks after intervention ]

6.  Secondary:   Fractional Flow Reserve (FFR) Value   [ Time Frame: at baseline and at 6-8 weeks after intervention ]

7.  Secondary:   Diameter Stenosis   [ Time Frame: Baseline and 6-8 weeks post intervention ]

8.  Secondary:   Post PCI Cardiac Enzymes   [ Time Frame: at 6-8 weeks after intervention ]

9.  Secondary:   Major Adverse Cardiac Events (MACE)   [ Time Frame: at 6-8 weeks after intervention ]

10.  Secondary:   Blood Chemistry - HsCRP   [ Time Frame: at baseline and at 6-8 weeks after intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations - small sample size and short duration of follow-up.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Pedro R. Moreno
Organization: Icahn School of Medicine at Mount Sinai
e-mail: pedro.moreno@mountsinai.org


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Annapoorna Kini, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01567826     History of Changes
Other Study ID Numbers: GCO 09-1294
IF1292822
First Submitted: March 28, 2012
First Posted: March 30, 2012
Results First Submitted: May 10, 2016
Results First Posted: February 27, 2017
Last Update Posted: May 19, 2017