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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn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
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