NCT01032668已完成3 期
The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths
研究概览
简要总结
Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance
详细描述
Aim:
Primary objective:
- To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance
Secondary objective:
- To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI
- To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI
- To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients; who have planned elective PCI and have had written informed consent for participation to study.
- •Age>18 year-old,
- •The native coronary artery;lesion with narrowing >=70%
排除标准
- •Patients have allergy for ASA, Clopidogrel and heparin
- •Patients who performed primary PCI
- •Patients with acute coronary syndrome
- •Patients with have a history of PCI and use clopidogrel
- •Patients on warfarin therapy
- •Patients who have bleeding diathesis, or have high risk for bleeding.
研究组 & 干预措施
high dose clopidogrel
Experimental
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths
时间窗: 6 months.
次要结局
- Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months.(6 months)
研究者
研究点 (1)
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