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Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

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.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: atorvastatin Drug: atorvastatin plus ezetimibe Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
Study Start Date : January 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: atorvastatin
patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
 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
Experimental: atorvastatin and ezetimibe
patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086020


Contacts
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Contact: Ruiyan Zhang, MD 862164370045 ext 665215 zhangruiyan@263.net
Contact: xin Chen, MD 862164370045

Locations
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China, Shanghai
Ruijin Hospital, Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ruiyan Zhang, MD    862164370045 ext 665215    zhangruiyan@263.net   
Contact: Xin Chen, MD    862164370045 ext 665380    rjchenxin@yahoo.com.cn   
Principal Investigator: Ruiyan Zhang, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Weifeng Shen, MD Ruijin Hospital
More Information
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Responsible Party: Weifeng Shen, ruijin hospital, shanghai jiao tong university school of medicine
ClinicalTrials.gov Identifier: NCT01086020    
Other Study ID Numbers: RJH20100101
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: December 2009
Keywords provided by Shanghai Jiao Tong University School of Medicine:
IVUS
coronary plaque
regression
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
 Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors