Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

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

Tracking Information

• First Submitted Date: March 11, 2010
• First Posted Date: March 12, 2010
• Last Update Posted Date: April 4, 2011
• Study Start Date: January 2010
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 11, 2010): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2012
• Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01086020
• Other Study ID Numbers: RJH20100101
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Weifeng Shen, ruijin hospital, shanghai jiao tong university school of medicine
• Study Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Not Provided

Investigators

• Principal Investigator: Weifeng Shen, MD; Ruijin Hospital

• PRS Account: Shanghai Jiao Tong University School of Medicine
• Verification Date: December 2009