EUCTR2006-001232-42-GB进行中（未招募）1 期
The Pharmacogenetics of Aspirin Resistance - The Pharmacogenetics of Aspirin Resistance
Royal Group of Hospitals Trust0 个研究点目标入组 150 人开始时间: 2006年3月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy individuals, age 18 - 60 years.
- •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
- •Use of other anti-platelet drugs (thienopyridines, GPIIb/IIIa antagonists, dipyridamole) because these drugs would also interfere with platelet function assays;
- •Use of other non-steroidal anti-inflammatory drugs, because of pharmacodynamic interactions;
- •History of dyspepsia or peptic ulceration requiring treatment with proton pump inhibitor or H2-antagonist, in view of the increased risk of gastrointestinal haemorrhagic complications;
- •History of systemic inflammatory diseases, in view of the need for these patients to take anti-inflammatory drugs;
- •History of asthma;
- •Use of other medications including aspirin (including herbal preparations);
- •Family or personal history of bleeding disorders, in order to reduce the potential for haemorrhagic complications;
- •Use of oral anticoagulants;
- •Platelet count outside the normal range (150,000 - 450,000 / ml), as these patients require further investigation and aspirin use is contra-indicated in patients with significant thrombocytopaenia;
- •Significant anaemia (Hb < 10g/dl), as these patients may require further investigation;
- •Recent major surgery, in view of the potential for haemorrhagic complications;
- •Known significant malignant disease, in view of the potential for haemorrhagic complications;
- •Known aspirin allergy;
- •Women of childbearing potential, except in the following circumstances for the duration of the trial:
- •oMonogamous relationship and partner sterilized, or
- •oFor personal reasons not sexually active, or
- •oUse of double barrier methods of contraception
- •(in these situations the patient will sign an additional consent form to indicate that they will take measures to avoid becoming pregnant during the trial);
- •History of lactose intolerance;
- •History of gout;
- •History of severe renal or hepatic dysfunction;
- •Planned surgery during participation in trial;
- •Excessive alcohol ingestion (>40 units per week);
- •Inability to provide informed consent.
研究者
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