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To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose 1mg pitavastatin | Active Comparator | pitavastatin 1mg which is considered low dose statin will be administered for 36 months |
|
| High dose 4mg pitavastatin | Active Comparator | pitavastatin 4mg which is considered high dose statin will be administered for 36 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin 1mg | Drug | To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment | OCT will measure neointimal volume in every mm interval and will be averaged by dividing the total neointimal volume with the number of the segment analyzed. LCBI is the lipid volume index which is calculated automatically by the device, and LCBI > 400 is considered high lipid volume. | 12 months for OCT and NIRS |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of major adverse cardiovascular events during 12 months follow-up | Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization | 12 months for clinical events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do-Sun Lim, MD, PhD | Korea University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31752850 | Derived | Jeong HS, Hong SJ, Son S, An H, Kook H, Joo HJ, Park JH, Yu CW, Lim DS. Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up. Cardiovasc Diabetol. 2019 Nov 21;18(1):162. doi: 10.1186/s12933-019-0969-z. | |
| 30047013 | Derived |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058426 | Neointima |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| Pitavastatin 4mg | Drug | To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia |
|
|
| Placebo | Drug | To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia |
|
| Lim JW, Jeong HS, Hong SJ, Kim HJ, Kim YC, Kang BG, Jeon SM, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW. Effects of lowest-dose vs. highest-dose pitavastatin on coronary neointimal hyperplasia at 12-month follow-up in type 2 diabetic patients with non-ST elevation acute coronary syndrome: an optical coherence tomography analysis. Heart Vessels. 2019 Jan;34(1):62-73. doi: 10.1007/s00380-018-1227-0. Epub 2018 Jul 25. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |