Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
试验速览
- 阶段
- 4 期
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Incidence of Renal Artery Stenosis
研究概览
简要总结
The anastomotic and peripheral stenosis of the transplanted kidney artery is one of the most important causes of graft failure in renal transplantation. The injury of vascular intima and the formation of microthrombosis may play a significant role in the stenosis of transplanted renal artery of recipients. Inhibiting this process with aspirin may protects against the stenosis of transplanted renal artery.
This is a prospective, randomized, controlled, clinical trial to investigate the efficacy and safety of prevention of renal artery stenosis in recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with the first renal transplantation were stable;
- •Age ≥ 18 years old;
- •Other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time;
- •In the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection;
- •The rejection of acute and chronic renal transplantation was excluded;
- •The thrombus formation of transplanted kidney was excluded.
排除标准
- •Allergic or intolerable to aspirin;
- •Previous transplant history;
- •Take other anticoagulants or non steroidal anti-inflammatory drugs at the same time;
- •History of active gastrointestinal bleeding or severe peptic ulcer;
- •Patients with bleeding tendency or severe liver disease;
- •Cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months;
- •Acute and chronic rejection;
- •Thrombus formation of transplanted renal vessels;
- •Any condition that increases the risk of adverse events or discontinuation.
研究组 & 干预措施
Aspirin
干预措施: Aspirin 100mg (Drug)
Placebo (sugar pill)
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Renal Artery Stenosis
时间窗: 2 years
Renal artery stenosis is defined as the presence of post-transplant renal artery stenosis in recipients evaluated by ultrasonography or renal arteriography.
次要结局
- Renal Allograft Function(2 years)
- Incidence of Graft Loss(2 years)