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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atorvastatin | Active Comparator | patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years |
|
| atorvastatin and ezetimibe | Experimental | patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruiyan Zhang, MD | Contact | 862164370045 | 665215 | zhangruiyan@263.net |
| xin Chen, MD | Contact | 862164370045 |
| Name | Affiliation | Role |
|---|---|---|
| Weifeng Shen, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| atorvastatin plus ezetimibe | Drug | 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 |
|
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |