A Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis Treatment Using Data From the AURORA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,773
- 试验地点
- 1
- 主要终点
- Time to first major adverse cardiovascular event (MACE)
研究概览
简要总结
The purpose of this study is to evaluate which clinical and laboratory factors are associated with major adverse cardiovascular event (MACE) in chronic kidney disease (CKD) patients on dialysis.
The study will also establish a cardiovascular (CV) risk equation appropriate for this dialysis population.
详细描述
This study is a retrospective analysis of dialysis dependent CKD patients participating in AURORA. The retrospective analysis will be performed using the AURORA study database.
AURORA was a prospective clinical trial in which dialysis patients were randomly assigned to rosuvastatin or placebo, sponsored by AstraZeneca. Patients included in the AURORA study who had end stage renal disease (ESRD) and had been treated with regular hemodialysis or hemofiltration for at least 3 months. Patients were recruited from approximately 300 centers in 25 countries.
The clinical study data is held by AstraZeneca AB, Sweden.
No formal sample size calculation was performed. The sample size is based on the available data from the AURORA study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who participated in the AURORA study. In brief, men and women who had ESRD and had been treated with regular hemodialysis or hemofiltration for at least 3 months (patients were recruited from 280 centers in 25 countries).
排除标准
- •The major exclusion criteria in AURORA were statin therapy within the previous 6 months, expected kidney transplantation within 1 year, and serious hematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) that was predicted to limit life expectancy to less than 1 year.
- •Other exclusion criteria were a history of a malignant condition, active liver disease (indicated by an alanine aminotransferase level that was more than three times the upper limit of the normal range), uncontrolled hypothyroidism, and an unexplained elevation in the creatine kinase level to more than three times the upper limit of the normal range.
结局指标
主要结局
Time to first major adverse cardiovascular event (MACE)
时间窗: Up to a maximum of 5.6 years
A MACE is defined as a non-fatal myocardial infarction (MI), non-fatal stroke, and CV mortality.
次要结局
- Time to CV event: stroke (ischemic or hemorrhagic)(Up to a maximum of 5.6 years)
- Time to CV event: coronary revascularization therapy(Up to a maximum of 5.6 years)
- Time to CV event: MI(Up to a maximum of 5.6 years)
- Time to CV event: new onset heart failure(Up to a maximum of 5.6 years)
- Time to a composite of any CV events(Up to a maximum of 5.6 years)
- Time to CV event: unstable angina(Up to a maximum of 5.6 years)
- Time to CV mortality(Up to a maximum of 5.6 years)
- Time to all-cause mortality(Up to a maximum of 5.6 years)