NCT01653119Unknown不适用
Peking and Rotterdam on Mission to Reduce Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
研究概览
简要总结
The purpose of this study is to explore the effect of 20mg high loading dose of rosuvastatin on recurrent events in patients with established DM who is admitted for an ACS.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Men or women ≥40 years of age admitted with a clinical diagnosis of ACS. The diagnosis should be based on the combination of typical ischemic chest complaints and objective evidence of myocardial ischemia or myocardial necrosis as demonstrated by the electrocardiogram (ECG) or elevated cardiac markers, as follows:
- •Typical ischemic chest pain, lasting 10 minutes or more, within the preceding 24 hours, AND either
- •ECG changes indicative of myocardial ischemia within 24 hours after the onset of chest pain (ECG showing persistent or non-persistent ST-segment elevation >1.0 mm in two or more contiguous leads or dynamic ST-segment depression >1.0 mm in two or more contiguous leads) or
- •Elevated biomarkers of myocardial necrosis within 24 hours after the onset of chest pain (i.e. CK-MB >1 times the upper limit of normal of the local laboratory, or Troponin-T >0.1 ng/ml.
- •A diagnosis of DM type II prior to the index ACS
- •Written informed consent
排除标准
- •• Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).
- •Severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure NYHA-class III or IV (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).
- •Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of <30 ml/min/1.73m2, or renal dialysis.
- •Co-existent condition associated with a life-expectancy <12 months, or otherwise unlikely to appear at all scheduled follow-up visits.
- •Known serious or hypersensitivity reactions to HMG-CoA reductase inhibitors.
- •Triglyceride (TG) level ≥500 mg/dL (5.65 mmol/L) at screening, because patients with very high triglyceride levels warrant treatment with agents that may increase the risk of side effects associated with statin drugs.
- •Active liver disease or hepatic dysfunction, as determined by alanine aminotransferase (ALT [SGPT]) >3 x ULN or bilirubin levels >1.5 x ULN at screening.
- •Myopathy.
- •Not using effective contraceptive methods.
- •Participation in any investigational drug study less than 30 days prior to enrolment.
研究组 & 干预措施
High loading dose of rosuvastatin
Active Comparator
rosuvastatin 20mg/d×1w
干预措施: Rosuvastatin (Drug)
Routine rosuvastatin therapy
Active Comparator
rosuvastatin 10mg/d×1w
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS
时间窗: during 12 months follow-up
次要结局
- A composite of cardiovascular mortality or a clinical diagnosis of a non-fatal ACS(during 30 days follow-up)
研究者
Wei Gao
doctor
Peking University Third Hospital
研究点 (1)
Loading locations...
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