Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Coronary Artery Disease Clinical Trial

— AEPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01086020
• Other study ID #: RJH20100101
• Status: Recruiting
• Phase: Phase 4
• First received: March 11, 2010
• Last updated: April 1, 2011
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ruiyan Zhang, MD
• Phone: 862164370045
• Email: zhangruiyan[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• atorvastatin
Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years
• 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

Locations

Country	Name	City	State
China	Ruijin Hospital,	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes