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The aim of this study is to assess whether high intensive statin therapy could regress carotid atherosclerotic plaques as determined by High-Resolution Contrast Enhanced Magnetic Resonance imaging (CE-MRI).
Enrolled patients have a baseline CE-MRI examination for screening carotid atherosclerotic plaques and are randomized to either low dose of Rosuvastatin (5mg) group or high dose of Rosuvastatin (20mg) group. After 26 weeks, all patients received CE-MRI examination again and each pair of baseline and follow-up CE-MRI assessments was analyzed in a blinded fashion. Moreover, lipid level and major adverse cardiovascular events are also evaluated during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group (5mg) | Experimental | low dose Rosuvastatin |
|
| high dose group (20mg) | Experimental | high dose Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 5mg | Drug | drug intervention |
| |
| Rosuvastatin 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether 26 weeks of treatment with 5/20mg rosuvastatin results in regression of carotid atherosclerotic plaques as measured by CE-MRI | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular events | 26 weeks | |
| To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline. | 26 weeks | |
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Inclusion Criteria:
-Patients with coronary artery disease or carotid atherosclerotic plaque or hyperlipideimia or old myocardial infarction
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Buxing Chen, MD, Ph.D | Contact | 861067096572 | chbux@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | 100050 | China |
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| Drug |
drug intervention |
|
| To evaluate the change from baseline in liver function (AST/ALT) at 26 weeks |
| 26 weeks |
| To evaluate the change from baseline in renal function (serum creatine) at 26 weeks | 26 weeks |
| To evaluate the change from baseline in creatine kinase at 26 weeks | 26 weeks |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D003920 | Diabetes Mellitus |
| D052439 | Lipid Metabolism Disorders |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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