ISRCTN71079188已完成未知
The pharmacogenetics of aspirin resistance
Royal Group of Hospitals Trust (UK)0 个研究点目标入组 150 人开始时间: 2007年3月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
入选标准
- •Healthy individuals aged between 18 to 60 years
排除标准
- •Current exclusion criteria as of 01/10/2012
- •1. Use of other anti-platelet drugs (thienopyridines, GPIIb/IIIa antagonists, dipyridamole) because these drugs would interfere with platelet function assays
- •2. Use of other non-steroidal anti-inflammatory drugs, because of the pharmacodynamic interactions
- •3. History of dyspepsia or peptic ulceration requiring treatment with proton pump inhibitors/H2 antagonists, in view of the increased risk of gastrointestinal haemorrhage
- •4. History of systemic inflammatory diseases, in view of the need for these patients to take anti-inflammatory drugs
- •5. History of asthma
- •6. Use of other aspirin-containing medications (including herbal preparations)
- •7. Family or personal history of bleeding disorders
- •8. Use of oral anticoagulants
- •9. Platelet count outside the normal range (150,000 to 450,000/ml)
- •10. Significant anaemia (Haemoglobin [Hb] less than 10 g/dl)
- •11. Recent major surgery
- •12. Known significant malignant disease
- •13. known aspirin allergy
- •14.1 Pregnancy
- •14.2 Women of childbearing potential except in the following circumstances for the duration of the trial: 'monogamous relationship and partner sterilised' or 'for personal reasons not sexually active' or 'use of double barrier methods of contraception'
- •15. History of lactose intolerance, as lactose if the primary substance contained in the placebo
- •16. History of gout, as aspirin can precipitate gout
- •17. History of severe renal or hepatic dysfunction
- •18. Planned surgery during participation in trial
- •19. Excessive alcohol ingestion (more than 40 units per week)
- •20. Inability to provide informed consent
- •Previous exclusion criteria until 01/10/2012:
- •14. Pregnancy/women of childbearing potential
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