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Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

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ClinicalTrials.gov Identifier: NCT01086020
Recruitment Status : Unknown
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 12, 2010
Last Update Posted : April 4, 2011
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 12, 2010
Last Update Posted Date April 4, 2011
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
change of coronary artery plaque volume [ Time Frame: 1 year ]
The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
composite of adverse cardiac events [ Time Frame: 2 years ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Official Title  ICMJE Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: atorvastatin
    Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years
    Other Name: Lipitor
  • Drug: atorvastatin plus ezetimibe
    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
    Other Name: Lipitor and ezetrol
Study Arms  ICMJE
  • Active Comparator: atorvastatin
    patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
    Intervention: Drug: atorvastatin
  • Experimental: atorvastatin and ezetimibe
    patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years
    Intervention: Drug: atorvastatin plus ezetimibe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 11, 2010)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01086020
Other Study ID Numbers  ICMJE RJH20100101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weifeng Shen, ruijin hospital, shanghai jiao tong university school of medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Weifeng Shen, MD Ruijin Hospital
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP