The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA): A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- HUA ( serum uric acid level, μmol/L)
研究概览
简要总结
The deleterious effects of hyperuricemia (HUA) on cardiovascular disease (CVD) were well established. Aspirin is the most commonly prescribed antiplatelet agent for primary or secondary prophylaxis of CVD. Only a few short-term studies in the elderly suggested low-dose aspirin, e.g., 75-100 mg/day, increases serum urate by reducing urinary uric acid excretion. However, monitoring of renal function is currently not recommended. Little is known about the long-term effect of low dose aspirin on uric acid. The principal aim of this prospective cohort study therefore is to evaluate the renal effects of long-term aspirin (100 mg/d) administration in Chinese patients with coronary artery disease or other CVDs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 coronary artery disease (CAD) who underwent (Percutaneous Transluminal Coronary Intervention) PCI therapy, documenting angiographically at least one vessel stenosis ≥50% among major coronary arteries (left main, left anterior descending, left circumflex or right coronary artery) , manifesting clinically as latent CAD, stable CAD, unstable CAD, and acute myocardial infarction.
- •Patients with CAD without PCI therapy. They document angiographically at least one vessel stenosis ≥50% among major coronary arteries (left main, left anterior descending, left circumflex or right coronary artery) , and classified clinically as latent CAD, stable CAD, unstable CAD.
- •Patients without CAD who needs antiplatelet therapy for prophylaxis of ASCVD, documenting angiographically no vessel stenosis ≥50% among any of major coronary arteries (left main, left anterior descending, left circumflex or right coronary artery).
排除标准
- •Patients with severe conditions with life expectancy less than 12 months.
- •Patients with malignant tumor.
- •Severe Kidney disease: patients with acute kidney injury, nephritic syndrome, renal replacement therapy, kidney transplant or eGFR <30 mL/min/1.73 m
- •Contraindicated to antiplatelet therapy because of acute bleeding.
- •Patients who formerly administrated aspirin for at least one week or withdrawal of aspirin less than one month before enrollment.
- •Patients who formerly administrated UA lowering agents at least one month before enrollment.
- •Patients who formerly administrated, stopped or titrated doses of any of the following drugs at least one month before enrollment: losartan, irbesartan, fenofibrate, thiazide and loop diuretics.
- •Patients who administrated ticagrelor as antiplatelet agent one month before enrollment or since then.
研究组 & 干预措施
Aspirin
Aspirin 100mg
干预措施: Aspirin 100 mg (Drug)
Clopidogrel
Clopidogrel 75mg
干预措施: Clopidogrel 75mg (Drug)
结局指标
主要结局
HUA ( serum uric acid level, μmol/L)
时间窗: 24 months after enrollment
Two different days of fasting uric acid \>420 μmol/L and women \>360 μmol/L under normal purine diet.
Initiation of UA-lowering agents
时间窗: 24 months after enrollment
Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion
Gout attacks (ACR/EULAR classification criteria 2015)
时间窗: 24 months after enrollment
Gout attacks are confirmed according to ACR/EULAR classification criteria 2015
次要结局
- Renal impairment (serum creatine level, μmol/L)(24 months after enrollment)
研究者
Junbo Ge
Chief of Cardiology Department
Shanghai Zhongshan Hospital