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临床试验/NCT00839345
NCT00839345Temporarily Not Available不适用

Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection

Charles University, Czech Republic1 个研究点 分布在 1 个国家开始时间: 2009年2月9日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
Temporarily Not Available
发起方
试验地点
1

研究概览

简要总结

The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.

详细描述

Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test. We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder. Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment

研究设计

研究类型
Expanded Access

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • coronary artery disease verified by coronary angiography
  • percutaneous coronary intervention with stent implantation
  • standard indication for dual antiplatelet therapy

排除标准

  • scheduled surgical revascularization by aortocoronary bypass
  • insufficient cooperation of the patient
  • coagulopathy in history with a higher risk of bleeding
  • life expectancy shorter than 1 year
  • severe anemia with hemoglobin level< 10,0 g/dl
  • platelet count < 100,000)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavel Osmancik

Associate professor

Charles University, Czech Republic

研究点 (1)

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