NCT01584791已完成4 期
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The percentage of P2Y12 receptor inhibition
研究概览
简要总结
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Korean men and women between the age of 20 and 85
- •Patients who were diagnosed as having CAD
- •Patients who were planned to undergo PCI
排除标准
- •Patients who were not treated with PCI or intended to treat with PCI but failed
- •Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
- •Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
- •Patients who were had hypersensitivity to clopidogrel or aspirin
- •Patients who were had abnormal laboratory results indicative of liver disease
- •Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
- •Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
- •Patients who were had other contraindication to study drug
- •Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
研究组 & 干预措施
clopidogrel napadisilate + aspirin
Experimental
干预措施: clopidogrel napadisilate + aspirin (Drug)
clopidogrel bisulfate + aspirin
Active Comparator
干预措施: clopidogrel bisulfate + aspirin (Drug)
结局指标
主要结局
The percentage of P2Y12 receptor inhibition
时间窗: 4 weeks
次要结局
- Adverse events after study medication(4 weeks)
研究者
Hyo-Soo Kim
Professor, Department of Internal Medicine, Seoul National University Hospital
Seoul National University Hospital
研究点 (1)
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