NCT02060786已完成4 期
Point-of-Care Measurements of Platelet Inhibition After Clopidogrel Loading in Patients With Acute Coronary Syndrome: Comparison of Generic Clopidogrel Bisulfate (Plavitor®) With Original Clopidogrel Bisulfate (Plavix®)
Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年10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
- 90
- 试验地点
- 1
- 主要终点
- PRU level at 2 hours after clopidogrel loading
研究概览
简要总结
This study demonstrates the effect of generic clopidogrel bisulfate (Plavitor®) in comparison with the original clopidogrel bisulfate (Plavix®) in patients with acute coronary syndrome.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unstable angina or non-ST elevation myocardial infarction
- •Patients who are planned coronary angiography
- •Age >18 years, <75 years
- •Patients who agree to the study protocol
排除标准
- •Recent treatment with clopidogrel or pletaal or glycoprotein IIb/IIIa Rc antagonist
- •Active bleeding (peptic ulcer, trauma or intra-cranial hemorrhage)
- •Allergy to antiplatelet agent
- •Bleeding diasthesis (blood coagulation disorders, uncontrolled severe hypertension, history of severe bleeding)
- •History of drug abuse or alcohol abuse
- •ST elevation myocardial infarction
- •Low platelet count (< 100,000 /L) or abnormal results of PT or PTT
- •Liver disease ( bilirubin > 2 mg/dL, AST or ALT > 100 IU)
- •Renal failure ( Cr > 2.0 mg/dL)
- •Proton pump inhibitor, NSAIDs statin (except atorvastatin)
研究组 & 干预措施
original Clopidogrel Bisulfate (Plavix®)
Active Comparator
original Clopidogrel Bisulfate (Plavix®) 600mg loading
干预措施: original clopidogrel (Plavix® ) (Drug)
generic Clopidogrel Bisulfate (Plavitor®)
Experimental
generic Clopidogrel Bisulfate (Plavitor®) 600mg loading
干预措施: generic clopidogrel (Plavitor® ) (Drug)
结局指标
主要结局
PRU level at 2 hours after clopidogrel loading
时间窗: 2 hours after clopidogrel loading
次要结局
- PRU level by VerifyNow P2Y12 at 4 -, 8- and 24 hours after clopidogrel loading(4 -, 8- and 24 hours after clopidogrel loading)
- ARU level by VerifyNow before and 2 hours after loading(2 hours after loading)
- Composite of death, myocardial infarction, target vessel revascularization(at 30 days)
- Stent thrombosis by Academic Research Consortium definition(at 30 days)
- Incidence of TIMI major bleedings(at 30 days)
研究者
Seung-Jea Tahk
MD,PhD
Ajou University School of Medicine
研究点 (1)
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