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临床试验/EUCTR2008-007875-26-GB
EUCTR2008-007875-26-GB进行中(未招募)1 期

Modulation of Clot Structure and Platelet Function by Aspirin in Individuals with Diabetes: the role of aspirin dose and Glycaemic control - Aspirin in Diabetes

niversity of Leeds0 个研究点目标入组 96 人开始时间: 2009年7月6日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
96

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

  • patients with type 1 diabetes(T1DM), treated with insulin only
  • age 18 - 65
  • not taking any other medication
  • no significant medical history(see below)
  • using reliable contraception ie. oral contraceptive pill, intra-utering device, diaphragm + condom
  • Healthy volunteers as above but without T1DM
  • 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) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Any history of cardiovascular disease.
  • Prior treatment with aspirin, clopidogril or warfarin.
  • Regular previous or current treatment with non-steroidal anti-inflammatory drugs,
  • Current treatment with any medication other than insulin
  • History of acute coronary syndrome or stroke, deep vein thrombosis, pulmonary embolism, previous or current upper gastrointestinal pathology, malignancy or coagulation disorders.
  • Any individual found to have abnormal liver function (measured by ALT>3 fold upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation.
  • Control subjects will be excluded if found to have impaired glucose tolerance or diabetes measured according to current guidelines.
  • Not currently using contraception
  • Pregnant women will not be included in the study. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.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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