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临床试验/EUCTR2020-004913-11-NL
EUCTR2020-004913-11-NL进行中(未招募)1 期

genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease’ - GENPAD

Radboudumc0 个研究点目标入组 2,244 人开始时间: 2021年2月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Radboudumc
入组人数
2,244

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - age > 16 years
  • - obtained written informed consent
  • - indication for monotherapy clopidogrel 75mg once daily
  • - ankle-brachial index < 0.9 and/or toe brachial index < 0.5
  • - current or previous symptoms due to insufficient vascularization of one or two lower extremities, including intermittent claudication, pain at rest and/or gangrene (Rutherford category 1-6)
  • - consulting a vascular surgeon for diagnosis, treatment and/or follow-up of PAD symptoms
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 744
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1500

排除标准

  • - known CYP2C19*2 and *3 status
  • - treated with coumarins, Non-vitamin K Oral Anti-Coagulants, unfractionated heparin, low molecular weight heparins or double antiplatelet therapy for other indications
  • - contraindication for clopidogrel, acetylsalicylic acid and/or rivaroxaban
  • - life expectancy of less than 1 year
  • - pregnant or breastfeeding women
  • - unable to give informed consent

研究者

发起方
Radboudumc

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