ISRCTN79817966已完成2 期
Antiplatelet Treatment in Diabetes
niversity of Leeds (UK)0 个研究点目标入组 56 人开始时间: 2010年5月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Aged 18 less than 75 years, either sex
- •2. Type 2 diabetes mellitus
- •3. Currently taking aspirin 75 mg per day
- •4. Weight 60 kg or over
- •5. Must be able to give informed consent and comply with the protocol
- •7. Using reliable contraception, i.e., oral contraceptive pill, intrauterine device, diaphragm + condom
排除标准
- •1. Prior treatment with clopidogrel or prasugrel
- •2. Previous or current treatment with warfarin or non-steroidal inflammatory drugs (NSAID)
- •3. A history of acute coronary syndrome within 3 months of recruitment
- •4. Any history of coagulation or bleeding disorder, neoplastic disease, deep vein thrombosis, pulmonary embolism
- •5. Any previous or current upper gastrointestinal pathology
- •6. Any history of cerebral vascular accident or transient ischaemic attack
- •hypersensitiviy to the active substance (i.e., clopidogrel or prasugrel) or any of the excipients
- •7. Active pathological bleeding
- •8. Any individual found to have abnormal liver function (measured by alanine aminotransferase [ALT] greater than 3 times upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation
- •9. Weight less than 60 kg
- •10. Inadequate contraception (as described in inclusion criteria)
- •11. Pregnant and lactating women. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.
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