Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
atorvastatin
atorvastatin plus ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring IVUS, coronary plaque, regression
Eligibility Criteria
Inclusion Criteria:
- Willing to receive the coronary angiography and potential PCI therapy
Exclusion Criteria:
- Patients was treated by statins before randomization
- Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
- ST elevation myocardial infarction less than 7 days
- Without informed consent
- Abnormal liver function before randomization, (AST, ALT ≥ULN)
- Active hepatitis or muscular disease
- Impaired renal function with serum creatinine level > 3mg/dl
- Impaired left ventricular function with LVEF > 30%
- Participate in other studies
Sites / Locations
- Ruijin Hospital,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
atorvastatin
atorvastatin and ezetimibe
Arm Description
patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years
Outcomes
Primary Outcome Measures
change of coronary artery plaque volume
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
Secondary Outcome Measures
composite of adverse cardiac events
The secondary endpoint was the composite of adverse cardiac events (MACE), including cardiac death, non-fatal infarction and target vessel revascularization at two years after randomization.
Full Information
NCT ID
NCT01086020
First Posted
March 11, 2010
Last Updated
April 1, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01086020
Brief Title
Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Acronym
AEPP
Official Title
Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
5. Study Description
Brief Summary
Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
IVUS, coronary plaque, regression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Description
patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
Arm Title
atorvastatin and ezetimibe
Arm Type
Experimental
Arm Description
patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years
Intervention Type
Drug
Intervention Name(s)
atorvastatin plus ezetimibe
Other Intervention Name(s)
Lipitor and ezetrol
Intervention Description
Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years
Primary Outcome Measure Information:
Title
change of coronary artery plaque volume
Description
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
composite of adverse cardiac events
Description
The secondary endpoint was the composite of adverse cardiac events (MACE), including cardiac death, non-fatal infarction and target vessel revascularization at two years after randomization.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing to receive the coronary angiography and potential PCI therapy
Exclusion Criteria:
Patients was treated by statins before randomization
Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion
ST elevation myocardial infarction less than 7 days
Without informed consent
Abnormal liver function before randomization, (AST, ALT ≥ULN)
Active hepatitis or muscular disease
Impaired renal function with serum creatinine level > 3mg/dl
Impaired left ventricular function with LVEF > 30%
Participate in other studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruiyan Zhang, MD
Phone
862164370045
Ext
665215
Email
zhangruiyan@263.net
First Name & Middle Initial & Last Name or Official Title & Degree
xin Chen, MD
Phone
862164370045
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weifeng Shen, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital,
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD
Phone
862164370045
Ext
665215
Email
zhangruiyan@263.net
First Name & Middle Initial & Last Name & Degree
Xin Chen, MD
Phone
862164370045
Ext
665380
Email
rjchenxin@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Ruiyan Zhang, MD
12. IPD Sharing Statement
Learn more about this trial
Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
We'll reach out to this number within 24 hrs