NCT01830491已完成4 期
Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 162 人开始时间: 2009年3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
- 162
- 主要终点
- the percent inhibition of the platelet aggregation change
研究概览
简要总结
The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before > 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20 to 80 years
- •men and women with coronary artery disease who had been treated with drug-eluting stent placement before > 12 months
- •patients who had remained in a stable condition with a single antiplatelet agent, aspirin
- •patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography
排除标准
- •Patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period
- •Patients who were suffering from drug abuse or alcohol addiction
- •hypersensitivity to clopidogrel or aspirin
- •severe liver disease (ALT or AST ≥ 10 times the upper normal limit)
- •active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage
- •a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding)
- •pregnant or lactating women
- •women with childbearing potential who were not using an appropriate contraception method
- •had medical or mental contra-indications to the study treatment
研究组 & 干预措施
Clopidogrel napadisilate
Experimental
aspirin 100mg
干预措施: Clopidogrel (Drug)
Clopidogrel napadisilate
Experimental
aspirin 100mg
干预措施: aspirin 100mg (Drug)
clopidogrel bisulfate
Active Comparator
aspirin 100mg
干预措施: Clopidogrel (Drug)
clopidogrel bisulfate
Active Comparator
aspirin 100mg
干预措施: aspirin 100mg (Drug)
结局指标
主要结局
the percent inhibition of the platelet aggregation change
时间窗: baseline and 4weeks
次要结局
- the change of P2Y12 reaction unit (PRU)(baseline and 4weeks)
研究者
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