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This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients.
Eicosapentaenoic acid and statin therapy prevents cardiovascular events. However, the impact of these treatment in patients with in-stent neoatherosclerosis has not been clarified.
So, the investigators conducted LINK IT study. This study showed that eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.
However, it was insufficient to directly evaluate the efficacy of additional effect of EPA for neoatherosclerosis. Because, statin dose of two groups was different and type of stent was variety.
Therefore, the investigators designed a new prospective, randomized OCT study. The OCT operators randomly assigned 75 patients who were detected neoatherosclerosis on follow-up OCT examination after implanted everolimus eluting stent to three groups; 5mg/day of rosuvastatin therapy (low dose statin therapy group) or 10mg/day of rosuvastatin therapy (high dose statin therapy group) or 10mg/day of rosuvastatin and 1800mg/day of eicosapentaenoic acid therapy (EPA and statin therapy group). Serial coronary angiography and OCT were performed at 9 months after baseline OCT procedure.
This study aim is to evaluate the additional effect of eicosapentaenoic acid and dose up effect of rosuvastatin for neoatherosclerosis in coronary artery disease patients by comparing 3 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA and statin therapy group | Active Comparator | After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 9 months. |
|
| High dose statin therapy group | Active Comparator | After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for 9 months. |
|
| low dose statin therapy group | No Intervention | After randomization, patients with low dose statin therapy take low dose rosuvastatin (5mg/day) for 9 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA and rosuvastatin | Drug | To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 9 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in lipid index | mean lipid arc ✕ lipid length | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major cerebro-cardiovascular events(Nonfatal stroke, Nonfatal myocardial infarction, cardiovascular death) | 9 months |
| The change in minimum lumen area | OCT parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiromasa Otake, ph.D | Contact | +81-78-382-5846 | hotake@med.kobe-u.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe University Graduate School of Medicine, Department of Cardiology | Kobe | Hyōgo | 650-0017 | Japan |
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| High dose rosuvastatin | Drug | To take high dose rosuvastatin (10mg/day) for 9 months. |
|
| 9 months |
| The change in average neointimal thickness | OCT parameter | 9 months |
| The change in lipid arc | OCT parameter | 9 months |
| The change in lipid length | OCT parameter | 9 months |
| The change in thin cap fibroatheroma | OCT parameter | 9 months |
| The change in macrophage grade | OCT parameter | 9 months |
| The change in plaque volume | Near infrared spectroscopy intravascular ultrasound(NIRS-IVUS) parameter | 9 months |
| The change in max Lipid-core burden index | NIRS-IVUS parameter | 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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