Tailored Antiplatelet Therapy During Percutaneous Coronary Intervention in Patients With Diabetes Mellitus
The Effect of Point-of-care Platelet Function Assay Guided Antiplatelet Therapy on the Periprocedural Increase of Cardiac Enzymes.
The researchers aimed to investigate the effect of point-of-care platelet function assay on the periprocedural cardiac enzyme elevation in patients with diabetes mellitus.
All patients who are supposed to undergo coronary angiography were loaded with clopidogrel (300mg) and aspirin (300mg) at D-1. If patients were determined to implant coronary stent after diagnostic coronary angiography, their platelet function is assayed with Verifynow-ADP (Accumetrics). If patients have >270 unit in the assay, they are randomized to abciximab or control group. After successful stent implantation, cardiac enzymes (CK-MB, Troponin-I) are followed at 8hr, 16hr and 24hr. Clinical outcomes including bleeding complications are assessed at 1 month.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Seongnam、大韩民国
- Seoul National University Bundang Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients who were determined to implant drug-eluting coronary stent
- Diabetes mellitus (type 1 or 2)
Exclusion Criteria:
- Age <18 years or >80years
- Patients with acute myocardial infarction
- Patients with history of cerebral hemorrhage ever or ischemic infarction within 2 years
- Patients with history of major surgery (abdominal, thoracic, intraocular) within 6 months
- Patients who have have allergy to antiplatelet medications (aspirin, clopidogrel, abciximab)
- Patients who are on anticoagulation therapy
- Serum creatinine >2.0mg/dl or ALT/AST > 3 times of upper normal limit (120 U/L)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：控制
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Patients,who showed PRU >270 unit and were randomized to control group,were treated with conventional antiplatelet therapy (aspirin+clopidogrel) during PCI and follow up periods. Aspirin : D-1 300mg, D0-30 100mg qd Clopidogrel : D-1 300mg, D0-30 75mg qd
其他名称：
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实验性的：abciximab
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Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Peak cardiac enzyme level (CK-MB,troponin-I)
大体时间：within 24 hrs
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The investigators will check cardiac enzymes at 8hrs, 16hrs and 24hrs after percutaneous coronary intervention.
We will take the highest value among those measured at three time points as a patient's peak cardiac enzyme level.
The primary outcome of this study is to compare the peak cardiac enzyme level between two groups.
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within 24 hrs
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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major adverse cardiovascular events (MACE): a composite of cardiac death, myocardial infarction, ischemic stroke
大体时间：1 month
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1 month
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Bleeding complications (cerebrovascular, intraocular, bleeding which needs transfusion more than 2 pints)
大体时间：1 month
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1 month
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The rate of periprocedural myocardial infarction
大体时间：8hr, 16hr, 24hrs
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The definition of periprocedural myocardial infarction : cardiac enzyme increase more than three times of upper normal limit
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8hr, 16hr, 24hrs
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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