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Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular events. Enhancing stability of vulnerable plaque is probably the main reason by which statins reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT) are the major determinants of plaque vulnerability. So, it is very important to accurately evaluate changes in plaque after stains therapy.
Previous reports suggested that intensive lipid lowering therapy provide more significantly clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.
Current intravascular imaging modalities, such as optical coherence tomography (OCT) and intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information of coronary plaques. However, there were few studies aimed at monitoring the progression of coronary plaques in patients receiving statin therapy by OCT combined with IVUS.
Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg, atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by OCT and plaque burden by IVUS of coronary atherosclerotic plaques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: | Active Comparator | Atorvastatin 20mg |
|
| Group B: | Experimental | Atorvastatin 60mg |
|
| Group C: | Active Comparator | Rosuvastatin 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin 20mg/day |
| |
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effects of atorvastatin 20mg and atorvastatin 60mg on the changes of FCT assessed by OCT and plaque burden by IVUS. | 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the changes of FCT assessed by OCT and plaque burden by IVUS in comparisons of atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg. | 12 months | |
| To investigate the changes of remodeling index assessed by IVUS in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg |
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Inclusion Criteria:
Exclusion criteria:
Exit criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, MD,PhD | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27871242 | Derived | Dong N, Xie Z, Wang W, Dai J, Sun M, Pu Z, Tian J, Yu B. Comparison of coronary arterial lumen dimensions on angiography and plaque characteristics on optical coherence tomography images and their changes induced by statin. BMC Med Imaging. 2016 Nov 22;16(1):63. doi: 10.1186/s12880-016-0166-4. |
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| Drug |
Atorvastatin, 60mg/day |
|
| Rosuvastatin | Drug | Rosuvastatin,10mg/day |
|
| 12 months |
| To investigate the changes of macrophage infiltration semi-quantitatively by OCT in comparisons of atorvastatin 60 mg vs atorvastatin 20 mg,atorvastatin 60 mg vs rosuvastatin 10 mg, and atorvastatin 20 mg vs rosuvastatin 10 mg | 12 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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