Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: atorvastatin; Drug: atorvastatin plus ezetimibe

• Registration Number: NCT01086020
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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 available

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
atorvastatin	atorvastatin	patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years
atorvastatin and ezetimibe	atorvastatin plus ezetimibe	patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years

Primary Outcome Measures

Name	Time	Method
change of coronary artery plaque volume	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

Name	Time	Method
composite of adverse cardiac events	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.

Trial Locations

Locations (1)

Ruijin Hospital,; 🇨🇳 Shanghai, Shanghai, China