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临床试验/EUCTR2009-011907-22-GB
EUCTR2009-011907-22-GB进行中(未招募)1 期

Antiplatelet treatment in patients with diabetes mellitus: is there a difference between aspirin, clopidogrel and prasugrel - Antiplatelet Treatment in Diabetes

niversity of Leeds0 个研究点目标入组 56 人开始时间: 2010年3月15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
入组人数
56

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

入选标准

  • Age 18 - <75
  • Type 2 diabetes mellitus
  • currently taking aspirin 75mg per day
  • Weight 60kg or over
  • Must be able to give informed consent and comply with the protocol
  • Using reliable contraception ie. oral contraceptive pill, intra-uterine device, diaphragm + condom
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • prior treatment with clopidogrel or prasugrel
  • previous or current treatment with warfarin or non-steroidal inflammatory drugs
  • a history of acute coronary syndrome within 3 months of recruitment
  • any history of coagulation or bleeding disorder, neoplastic disease, deep vein thrombosis, pulmonary embolism. Any previous or current upper gastrointestinal pathology
  • any history of cerabral vascular accident or transient ischaemic attack
  • hypersensitiviy to the active substance (ie clopidogrel or prasugrel) or any of the excipients
  • active pathological bleeding
  • any individual found to have abnormal liver function (measured by ALT>3times upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation
  • Weight less than 60kg
  • inadequate contraception (as described in inclusion criteria)
  • pregnant and lactating women will be excluded. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn

研究者

发起方
niversity of Leeds

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