NCT01763749已完成4 期
Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label 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
- 91
- 试验地点
- 1
- 主要终点
- Change from baseline in P2Y12% inhibition at week 4
研究概览
简要总结
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.
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
- •Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
- •20~85 years old
- •Willing to adhere to protocol requirements and sign a informed consent form
排除标准
- •Subject who did not undergo or failed Stent Implantation
- •Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
- •Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
- •Subjects with uncontrolled severe hypertension
- •Subjects with high risk of hemorrhage like blood coagulation disorders
- •:gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
- •Subjects with intractable arrhythmia, intracranial hemorrhage
- •Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
- •Subjects with Severe hepatopathy(AST and ALT > 10 times the upper limit of normal)
- •Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
Closone
Experimental
75mg/100mg per day, 4weeks, PO
干预措施: Closone (Drug)
Plavix with Astrix
Active Comparator
Plavix 75mg with Astrix 100mg, 4weeks, PO
干预措施: Plavix with Astrix (Drug)
结局指标
主要结局
Change from baseline in P2Y12% inhibition at week 4
时间窗: Baseline, week 4
次要结局
- Change from baseline in VerifyNow P2Y12 reaction unit at week 4(Baseline, week 4)
- Change from baseline in maxymal platelet aggregation at week 4(Baseline, week 4)
- Change from baseline in VerifyNow Aspirin Reaction Unit at week 4(Baseline, week 4)
研究者
Kiyuk Chang
Associate professor
Seoul St. Mary's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and ClosoneCoronary Artery DiseaseNCT01765452HK inno.N Corporation285
已完成
4 期
The efficacy of Palvix and Clopidex in Post-Stroke patientsIRCT201011025073N1Baqiyatallah University of Medical Sciences120
已完成
3 期
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)AsthmaNCT00163358AstraZeneca630
已完成
4 期
SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT00361959GlaxoSmithKline1,270
已完成
4 期
Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD EquivalentsCoronary Heart DiseaseNCT00947843Seoul National University Hospital306