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临床试验/NL-OMON53494
NL-OMON53494招募中4 期

Body Weight Adjusted Clopidogrel treatment in patients with CORonary artery Disease (BW-ACCORD) - BW-ACCORD

Sint Antonius Ziekenhuis0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • - Patients, male or female, >=18 years of age
  • - Patients treated for coronary artery disease with clopidogrel 75mg QD
  • (aspirin 100mg QD).
  • - Patients must be treated with clopidogrel 75mg for at least one month
  • - Patients must give consent by means of a signed informed consent

排除标准

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • - Contra-indication for aspirin
  • - Contra-indication for clopidogrel or prasugrel
  • - Occurrence of an ischemic event after PCI or ACS (stroke, myocardial
  • infarction, or coronary revascularization)
  • - Presence of unstable angina complaints.
  • - Presence of two CYP2C19 Loss-of-function (LOF) alleles (*2 or *3)
  • - Scheduled for cardiac valve surgery
  • - Indication for chronic oral anticoagulants
  • - Expected life span of less than one year
  • - Pregnancy
  • - Suboptimal stent placement as determined by the cardiologist.
  • - Patients at increased risk of bleeding with two of the following
  • characteristics: liver cirrhosis with portal hypertension, enhanced bleeding
  • tendency, active malignancy in the past 12 months, thrombocytopenia, major
  • surgery in the past month, spontaneous intracerebral haemorrhage, traumatic
  • intracerebral haemorrhage in the past 12 months, major bleeding requiring
  • hospitalisation or blood transfusion in the past month, ischaemic CVA in the
  • past 5 months.
  • - Known with established stent thrombosis

研究者

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