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临床试验/NCT00444132
NCT00444132已完成3 期

Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年3月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Platelet reactivity

研究概览

简要总结

Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

详细描述

Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be non-responders to a conventional dose of clopidogrel. This phenomenon has been associated with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage, thrombotic complications, and ischemic events in patients undergoing elective percutaneous coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in platelet aggregation, although the patients were not non-responders. Despite this, the effect of dose escalation has never been examined in patients resistant to clopidogrel. In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • age equal or over 18 years
  • acute coronary syndrome
  • Clopidogrel non-responsive
  • signed an informed consent

排除标准

  • Bleeding disorder
  • hypersensitivity to aspirin or clopidogrel
  • any contraindication to anti-thrombotic or anticoagulant therapy
  • active neoplastic disorder

结局指标

主要结局

Platelet reactivity

次要结局

  • recurrent ACS
  • stroke
  • death

研究者

申办方类型
Other Gov

研究点 (1)

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