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Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01086020
First received: March 11, 2010
Last updated: April 1, 2011
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: atorvastatin
Drug: atorvastatin plus ezetimibe
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • change of coronary artery plaque volume [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 400
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086020

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

Locations
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
Principal Investigator: Weifeng Shen, MD ruijin hospital, Shanghai Jiao Tong University, School of Medicine
  More Information

No publications provided

Responsible Party: Weifeng Shen, ruijin hospital, shanghai jiao tong university school of medicine
ClinicalTrials.gov Identifier: NCT01086020     History of Changes
Other Study ID Numbers: RJH20100101
Study First Received: March 11, 2010
Last Updated: April 1, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
IVUS
coronary plaque
regression

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Ezetimibe
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013