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This study is a prospective randomized trial to evaluate and compare the quantitative and qualitative characteristics of neointimal formation between high and low efficacy statin treatment after drug eluting stent (DES) implantation, in patients with homogeneous or heterogeneous neointimal pattern accessed by Optical Coherence Tomography (OCT). The investigators postulate that high efficacy statin could have superior effect on modification of neointimal pattern, compared with lower efficacy statin. Our main hypothesis is that Atorvastatin 40mg, high efficacy statin might have superior effect on modification of neointimal pattern evaluated by serially followed OCT, compared with pravastatin 20mg in patients with DES implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High efficacy statin group (homogeneous) | Experimental | homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group |
|
| Low efficacy statin group (homogeneous) | Active Comparator | homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 40mg | Drug | homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of neointimal patterns assessed by 1-year followed OCT | Qualitative neointimal pattern measured by OCT such as restenotic tissue structure | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| stent coverage and neointimal thickness | Change of stent coverage and neointimal thickness assessed by 1-year followed OCT | at 1 year |
| Major adverse cardiac events | MACE (Major adverse cardiac events) including cardiovascular/unexpected mortality, non-fatal myocardial infarction, target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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| pravastatin 20 mg | Drug | Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group |
|
|
| at 1 year |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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