NCT01241903已完成1 期
Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Susan Smyth1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Platelet - Leukocyte Aggregates
研究概览
简要总结
The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be between 18 and 80 years old.
- •Subjects must be willing and able to give informed consent
- •A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
- •Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.
- •Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
排除标准
- •Age <18 years
- •Age > 80 years
- •Use of Crestor in the past 30 days
- •GFR (estimated) <30 ml/min
- •Hemodialysis
- •History of liver failure
- •Unexplained liver function abnormalities
- •Current or planned use of cyclosporine or gemfibrozil
- •Hypotension
- •Dehydration
- •Severe metabolic, endocrine or electrolyte abnormality
- •Recent (within the last 2 weeks) or planned (in the next month) major surgery
- •HIV/AIDS with current of planned use of HIV protease inhibitors
研究组 & 干预措施
Crestor
Experimental
干预措施: rosuvastatin (Drug)
sugar pill
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Platelet - Leukocyte Aggregates
时间窗: within first 24 hours
measured by flow cytometry
次要结局
- Biomarkers of Platelet Function and Myocardial Necrosis(up to 30 days)
研究者
Susan Smyth
Principal investigator
University of Kentucky
研究点 (1)
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