Atorvastatin Plus Ezetimibe on Coronary Plaque Progression

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: atorvastatin
* Drug: atorvastatin plus ezetimibe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atorvastatin<br>patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years | Drug: atorvastatin<br>* Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years<br>* Other names: Lipitor;|
| Experimental: atorvastatin and ezetimibe<br>patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years | Drug: atorvastatin plus ezetimibe<br>* 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<br>* Other names: Lipitor and ezetrol;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVUS, coronary plaque, regression