Atorvastatin Plus Ezetimibe on Coronary Plaque Progression (AEPP)

Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: atorvastatin; Drug: atorvastatin plus ezetimibe

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ruiyan Zhang, MD; Phone Number: 665215 862164370045; Email: zhangruiyan@263.net
• Study Contact Backup: Name: xin Chen, MD; Phone Number: 862164370045

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital,
      • Contact: Ruiyan Zhang, MD; Phone Number: 665215 862164370045; Email: zhangruiyan@263.net
      • Contact: Xin Chen, MD; Phone Number: 665380 862164370045; Email: rjchenxin@yahoo.com.cn
      • Principal Investigator: Ruiyan Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Lipitor and ezetrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Weifeng Shen, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimate): March 12, 2010

Study Record Updates

• Last Update Posted (Estimate): April 4, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: regression; IVUS; coronary plaque
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: RJH20100101