NCT01198379撤回4 期
Efficacy of Monitoring of Aspirin Responsiveness in the Prevention of Cardiovascular Events and Decrease in Bleeding Complications in Patients With End-Stage Kidney Disease Undergoing Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- the prevalence of aspirin resistance
研究概览
简要总结
The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with end-stage renal disease who are undergoing long-term hemodialysis.
排除标准
- •Patients will be excluded if there is evidence of
- •a recent history of acute uremia,
- •previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema),
- •concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs,
- •high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or
- •life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).
研究组 & 干预措施
Aspirin
Experimental
干预措施: aspirin (Drug)
Sugar pills
Placebo Comparator
Hemodialysis (HD) patients receive placebo not containing aspirin in this study.
干预措施: Placebo (Drug)
结局指标
主要结局
the prevalence of aspirin resistance
时间窗: 3 years
次要结局
- the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure)(3 years)
研究者
研究点 (1)
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