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YELLOW II Study: Reduction in Coronary Yellow Plaque, Lipids and Vascular Inflammation by Aggressive Lipid Lowering

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ClinicalTrials.gov Identifier: NCT01837823
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Texas Heart Institute (Wafic Said Molecular Cardiology Research Lab)
AstraZeneca
InfraReDx (indirect)
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Obstructive Coronary Artery Disease
Coronary Artery Disease
Intervention: Drug: rosuvastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in July 2013, with enrollment from August 2013 to February 2015, 91 patients with multivessel CAD, who underwent percutaneous coronary intervention (PCI) for a culprit lesion followed by OCT and NIRS/IVUS imaging of an obstructive NCL were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rosuvastatin All subjects will receive rosuvastatin 40mg/day 8-12 weeks

Participant Flow:   Overall Study
    Rosuvastatin
STARTED   91 
COMPLETED   85 
NOT COMPLETED   6 
Lost to Follow-up                6 



  Baseline Characteristics

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
Rosuvastatin All subjects will receive rosuvastatin 40mg/day 8-12 weeks

Baseline Measures
   Rosuvastatin 
Overall Participants Analyzed 
[Units: Participants]
 85 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.4  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      58  68.2% 
Male      27  31.8% 
Hypertension 
[Units: Participants]
Count of Participants
 76 
Hypercholesterolemia 
[Units: Participants]
Count of Participants
 75 
Diabetes mellitus 
[Units: Participants]
Count of Participants
 37 
Body mass index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.6  (5.2) 
Current smoking 
[Units: Participants]
Count of Participants
 12 
History of smoking 
[Units: Participants]
Count of Participants
 26 
Prior myocardial infarction (MI) 
[Units: Participants]
Count of Participants
 12 
Prior percutaneous coronary intervention (PCI) 
[Units: Participants]
Count of Participants
 24 
Statin use 
[Units: Participants]
Count of Participants
 
atorvastatin      29  34.1% 
simvastatin      23  27.1% 
rosuvastatin      12  14.1% 
pravastatin      4   4.7% 
fluvastatin      1   1.2% 
none      16  18.8% 
Location of coronary artery disease 
[Units: Participants]
Count of Participants
 
the left anterior descending artery (LAD)      36  42.4% 
left circumflex artery (LCX)      23  27.1% 
the right coronary artery (RCA)      26  30.6% 


  Outcome Measures

1.  Primary:   Correlation Between Plaque Morphology and HDL Functionality   [ Time Frame: baseline and 8-12 weeks ]

2.  Primary:   Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP   [ Time Frame: baseline and 8-12 weeks ]

3.  Secondary:   Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max)   [ Time Frame: baseline and at 8-12 weeks ]

4.  Secondary:   Fibrous Cap Thickness (FCT) by OCT   [ Time Frame: baseline and at 8-12 weeks ]

5.  Secondary:   IVUS Imaging Measures   [ Time Frame: Baseline and 8 weeks ]

6.  Secondary:   Inflammatory and Lipid Parameters   [ Time Frame: baseline and at 8-12 weeks ]

7.  Secondary:   Lesion LCBI   [ Time Frame: at baseline and at 8-12 weeks ]

8.  Secondary:   LCBI 4mm at Same Anatomical Site   [ Time Frame: at baseline and at 8-12 weeks ]

9.  Secondary:   Change in Atheroma Volume   [ Time Frame: baseline and at 8-12 weeks ]

10.  Secondary:   Biomarker Release   [ Time Frame: within 24 hrs of PCI ]

11.  Secondary:   Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max   [ Time Frame: baseline ]

12.  Secondary:   Plaque Morphology as Related to Haptoglobin   [ Time Frame: baseline and at 8-12 weeks ]

13.  Secondary:   Mechanism of Reverse Cholesterol Transport   [ Time Frame: baseline and at 8-12 weeks ]

14.  Secondary:   Correlation of Changes in Plaque Morphology   [ Time Frame: baseline and at 8-12 weeks ]

15.  Secondary:   MACE   [ Time Frame: at 30 days ]

16.  Secondary:   MACE   [ Time Frame: at 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

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


Results Point of Contact:  
Name/Title: Dr. Annapoorna Kini
Organization: Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai
phone: 212-241-4181
e-mail: annapoorna.kini@mountsinai.org


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: NCT01837823     History of Changes
Other Study ID Numbers: GCO 12-1507
HS#: 12-00741
First Submitted: April 5, 2013
First Posted: April 23, 2013
Results First Submitted: January 9, 2017
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018