A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3,548
- 试验地点
- 7
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.
This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.
详细描述
IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults Aged 19 and up
- •Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)
- •For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test
- •Patients who agreed and signed on the informed consent form
排除标准
- •Patients with life expectancy of a year or less due to malignancy
- •Patients with chronic liver disease
- •Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.
- •Pregnant and/or breastfeeding
- •Female patients who are unable to use any means of contraception
- •Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
- •Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)
- •Patients considered inappropriate for the study for any other reason(s) by the inspector(s)
研究组 & 干预措施
ezetimibe 10 mg plus rosuvastatin 5 mg
Rosuzet 5/10 mg , once a day for 24 months
干预措施: Ezetimibe 10mg + Rosuvastatin 5mg (Drug)
rosuvastatin 20 mg only
Any brand drugs of rosuvastatin 20mg, once a day for 24 months
干预措施: Rosuvastatin 20mg (Drug)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 24 months
A composite of cardiovascular death, major coronary events (non-fatal MI, documented unstable angina requiring hospital admission, all coronary revascularization with either PCI or bypass surgery occurring at least 30 days after randomization), or non-fatal stroke.
次要结局
- cardiovascular death(24months)
- any stroke(24 months)
- Rate of Statin associated muscle symptoms(3 months)
- death from any cause, a major coronary event, or a non-fatal stroke(24 months)
- all-cause death from any cause(24months)
- LDL-C reduction <= 55mg/dl(3 months)
- new onset diabetes(24 months)
- cataract(24 months)
- cardiovascular death, non-fatal MI, or non-fatal stroke(24 months)
- pill count drug adherence(24 months)
- any myocardial infaction(24 months)
- any revascularization occurring at least 30 days after randomization(24 months)
- LDL-C reduction <= 70mg/dl(3 months)
- drug discontinuation or dose reduction(24 months)
研究者
Kiyuk Chang, MD,PhD
Professor of Medicine
The Catholic University of Korea