Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using OCT
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The change in lipid index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •over 20 years
- •Patients implanted everolimus-eluting stent(EES) neoatherosccrelosis with neoatherosclerosis by OCT
- •LDL is or less than 100 mg/dl after ingesting 5 mg/day of rosuvastatin
排除标准
- •Patients taking omega 3 fatty acid before randomization
- •Patients allergic to rosuvastatin or eicosapentaenoic acid
- •Patients with a history of hemorrhagic stroke
- •Patients taking anti cancer agent
- •Patients undergoing LDL apheresis
- •Patients with severe liver disease or severe kidney disease
- •Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of rosuvastatin
- •Patients who conflict with any of the warnings or contraindications listed in the domestic package insert of eicosapentaenoic acid
- •Patients performed percutaneous coronary intervention with restenosis of target lesion
- •Pregnant women or patients with possibility of Pregnancy or nursing woman
研究组 & 干预措施
EPA and statin therapy group
After randomization, patients with combination therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
干预措施: EPA and rosuvastatin (Drug)
High dose statin therapy group
After randomization, patients with high dose statin therapy start high dose rosuvastatin (10mg/day) for ９ months.
干预措施: High dose rosuvastatin (Drug)
结局指标
主要结局
The change in lipid index
时间窗: 9 months
mean lipid arc ✕ lipid length
次要结局
- The change in minimum lumen area(9 months)
- The change in lipid length(9 months)
- The change in thin cap fibroatheroma(9 months)
- The change in macrophage grade(9 months)
- The change in plaque volume(9 months)
- MACE(9 months)
- The change in average neointimal thickness(9 months)
- The change in lipid arc(9 months)
- The change in max Lipid-core burden index(9 months)
研究者
Hiromasa Otake
Senior Lecturer
Kobe University