NCT01050348已完成4 期
A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction
The Western Pennsylvania Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.
研究概览
简要总结
This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.
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
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram.
- •Elevated cardiac biomarkers (troponin-T > 0.03ng/ml, CKMB>5ng/mL, or ck>170 U/l).
排除标准
- •Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure.
- •Renal failure with creatinine >3mg/dL
- •Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer.
- •Cardiovascular arrest and shock.
研究组 & 干预措施
Sugar Pill
Placebo Comparator
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
干预措施: Inactive Placebo (Drug)
Atorvastatin calcium
Active Comparator
Patients will receive study medication upon admission to hospital prior to percutaneous intervention of the culprit artery
干预措施: Atorvastatin calcium (Drug)
结局指标
主要结局
Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.
时间窗: 15 and 30 days post revascularization
次要结局
- Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.(15 and 30 days post revascularization)
- Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)(15 and 30 days post revascularization)
- Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG.(15 and 30 days post revascularization)
- Symptomatic side effects of current statin medication as described by adverse effects on consent form.(Immediately post revascularization to 30 days.)
研究者
研究点 (2)
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