Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular outcome
研究概览
简要总结
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.
详细描述
With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation.
In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients.
This trial was designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after PCI in the era of the newer generation DES era.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent percutaneous coronary intervention with drug-eluting stent;
排除标准
- •Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;
- •Serum creatinine level > 2.0 mg/dL
- •Serum aspartate transaminase > 3 times upper limit of normal
- •Serum alanine transaminase > 3 times upper limit of normal
- •Having anaphylactic reaction for Rosuvastatin;
- •Having the other contraindications for Rosuvastatin;
- •Having plan to be pregnant;
- •Having life expectancy less than 1 year
研究组 & 干预措施
Rosuvastatin 5mg
Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention
干预措施: Rosuvastatin 5mg (Drug)
Rosuvastatin 20mg
Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
Major adverse cardiovascular outcome
时间窗: Baseline to Final visit (30 months)
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
次要结局
- Repeat revascularization(Baseline to Final visit (30 months))
- Target LDL-C level achievement(6 months of treatment and thereafter)
- All-cause death(Baseline to Final visit (30 months))
- Cardiac death(Baseline to Final visit (30 months))
- Level change of other biomarkers(Baseline to 6 months of treatment and thereafter)
- Non-fatal myocardial infarction(Baseline to Final visit (30 months))
- HDL-C level change(Baseline to 6 months of treatment and thereafter)
- Stent thrombosis(Baseline to Final visit (30 months))
- LDL-C level change(Baseline to 6 months of treatment and thereafter)
研究者
Hyung Joon Joo
Professor, assistant
Korea University Anam Hospital