Effect of Aspirin in Primary Prevention of Cardiovascular Risk in Patients With Chronic Kidney Disease (AASER Study)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Cardiovascular events
研究概览
简要总结
The objective of the study is to examine whether the use of low-dose aspirin (75-100 mg / day) reduces the risk of cardiovascular disease in patients with chronic kidney disease (stage 3 or 4).
详细描述
Hypothesis
The low-dose aspirin reduces cardiovascular risk in patients with chronic kidney disease without increasing the risk of bleeding
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
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign informed consent
- •males 45-79 years or females 55-79 years. -Stage 3 or 4 CKD (estimated GFR by MDRD abbreviated, between 15 and 60 ml / min/1.73 m2) -
排除标准
- •a previous cardiovascular event: cardiac arrhythmias, cardiac arrest, angina or acute myocardial infarction, stroke, carotid stenosis of more than 50%, peripheral vascular arteriopathy documented
- •hospitalization for any cause in the last three months prior to inclusion in the study allergy of acetyl-salicylic acid
- •coagulopathy from any cause
- •thrombocytopenia <150,000 platelets
- •liver disease from any cause
- •Infection by hepatitis B virus, hepatitis C or HIV
- •immunosuppressive treatment within 12 weeks before inclusion in the study
- •Major bleeding events including gastrointestinal bleeding and brain hemorrhage.
- •hemoglobinopathies (eg sickle cell disease or thalassemia of any kind)
- •active malignancy (except non-melanoma skin cancer). May be included in the study patients with malignant neoplasia who have remained disease-free for at least the previous 5 years.
- •uncontrolled inflammatory disease or symptomatic (eg rheumatoid arthritis, lupus, Chrom disease or bowel inflammatory disease)
- •hemolysis
- •treatment with oral anticoagulation and / or antiplatelet therapy prior.
- •poorly controlled hypertension (> 160/90 mm Hg) -pregnancy or breast-
- •women of childbearing potential not using effective contraception.
研究组 & 干预措施
aspirin
Aspirin dosage 100 mg/day
干预措施: Aspirin (Drug)
结局指标
主要结局
Cardiovascular events
时间窗: five years
To assess the benefit of treatment with low-dose aspirin in the primary prevention of cardiovascular events (incidence of the composite endpoint: death, acute coronary syndrome, stroke or nonfatal acute peripheral arteriopathy disease) in patients with chronic kidney disease who are not in dialysis or renal transplant.
次要结局
- Major bleeding(five years)
- antiinflammatory effects of aspirin(five years)
研究者
Jose Luño Fernandez
Headmaster of Nephrology Department
Fundación de Ayuda a la Investigación sobre la Hipertensión, Riesgo Cardiovascular y Enfermedades Renales