Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 448
- 主要终点
- % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
研究概览
简要总结
The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.
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
- •Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
- •Korean men and women between the age of 20 and 85
- •Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.
排除标准
- •Patients who were not treated with PCI or intended to treat with PCI but failed.
- •Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
- •Patients who had a history of alcohol abuse or intoxication.
- •Patients who had hypersensitivity to clopidogrel or aspirin.
- •Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
- •Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
- •Patients who were pregnant, breastfeeding.
- •Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
- •Patients who medically, psychologically had investigational product administration's prohibition.
- •Patients who were not participated in this clinical trial decided by other investigators.
研究组 & 干预措施
Clopirin 1
Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.
干预措施: Clopirin 1 (Drug)
Clopidogrel/Aspirin co-administration 1
Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.
干预措施: Clopidogrel-Aspirin(co-administration) 1 (Drug)
Clopirin 2
Clopirin single-administration. Before this clinical trial Aspirin single-administration.
干预措施: Clopirin 2 (Drug)
Clopidogrel/Aspirin co-administration 2
Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.
干预措施: Clopidogrel-Aspirin(co-administration) 2 (Drug)
结局指标
主要结局
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU
时间窗: 8 weeks
次要结局
- △ PRU = Post treatment PRU - Pre treatment PRU(8 weeks)
- △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU(8 weeks)