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This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin 20 mg | Experimental | Rosuvastatin 20 mg for 76 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin 20 mg per day for 76 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks | 76 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood lipids at 26 weeks | 26 weeks | |
| Change from baseline in hsCRP at 26 weeks | 26 weeks | |
| Change from baseline in Carotid intima-media thickness at 76 weeks |
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Inclusion Criteria:
Written informed consent
Men or women, aged 18 -75
Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one:
Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl)
The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Jiang, MD | Contact | 86-10-66551383 | jiangjie@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yong Huo, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| 76 weeks |
| Number of participants with adverse events and abnormal laboratory safety markers. | 76 weeks |
| Change from baseline in blood lipids at 52 weeks | 52 weeks |
| Change from baseline in blood lipids at 76 weeks | 76 weeks |
| Change from baseline in hsCRP at 52 weeks | 52 weeks |
| Change from baseline in hsCRP at 76 weeks | 76 weeks |
| Division of Cardiology, Peking University First Hospital | Recruiting | Beijing | 100034 | China |
|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |