NCT00947843已完成4 期
Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
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
- 306
- 主要终点
- The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
- •Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
- •History of PCI or coronary artery bypass graft surgery (CABG) > one year or
- •Diabetes mellitus (including type I and type II) or
- •Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
- •History of peripheral artery disease or
- •History of cerebrovascular disease
排除标准
- •Patients who had history of PCI within one year
- •Patients who used concomitant anticoagulants
- •Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
- •Chronic alcoholism or drug addiction
- •Women who were pregnant or breastfeeding or who were not using an effective method of contraception
- •The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug
研究组 & 干预措施
aspirin+placebo
Placebo Comparator
aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
干预措施: aspirin + placebo (Drug)
aspirin+pregrel
Active Comparator
pregrel is a generic brand name of clopidogrel
干预措施: aspirin + pregrel (Clopidogrel resinate) (Drug)
Aspirin+Plavix
Active Comparator
plavix is a original brand name of clopidogrel
干预措施: aspirin + plavix (Clopidogrel bisulfate) (Drug)
结局指标
主要结局
The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%))
时间窗: 1 month
次要结局
- Adverse events after study medication(1 month)
研究者
Hyo-Soo Kim
Principal investigator
Seoul National University Hospital
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