Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Infarct size measured by cardiac MRI
研究概览
简要总结
Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy (rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter) versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10 mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The infarct size in the early high dose rosuvastatin group is smaller than that of the control patients treated with low does conventional statin therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient had the symptoms of acute myocardial infarction within 12 hours with ST-segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
- •Male or female over 20 years of age
- •Signed written informed consent to participate in the study
排除标准
- •Congestive heart failure (NYHA Class III or IV) or LVEF <35%.
- •Clinically significant heart disease requiring CABG, cardiac transplantation, surgical repair and/or replacement during the course of the study.
- •Previous MI or CABG
- •Known serious or hypersensitivity reactions to statin, antiplatelet agents (aspirin or clopidogrel), or heparin.
- •Known familial hypercholesterolemia
- •Known skeletal muscle disease
- •Known active liver disease such as hepatitis or liver cirrhosis (except for fatty liver)
- •Renal failure (Cr >2.0 mg/dL)
- •Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism, and/or nephrotic syndrome
- •Non-cardiac comorbidity with a life expectation < 1 year
- •Contraindications to CMRI (eg, implanted pacemaker or cardiac defibrillator, claustrophobia, etc.)
- •Pregnant or lactating women or women of childbearing potential
- •Participation in any investigational drug or device study within 30 days prior to study entry
研究组 & 干预措施
Early intensive rosuvastatin therapy
干预措施: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) (Drug)
Conventional statin therapy
干预措施: Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI) (Drug)
结局指标
主要结局
Infarct size measured by cardiac MRI
时间窗: day 3-7
次要结局
未报告次要终点