The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA）
赞助:
Shanghai Zhongshan Hospital
合作者:
信息的提供 (责任方):
Junbo Ge，Shanghai Zhongshan Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | November 1, 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
HUA[ Time Frame: 24 months after enrollment ] hyperuricemia Gout attacks[ Time Frame: 24 months after enrollment ] ACR/EULAR classification criteria 2015 Initiation of UA-lowering agents[ Time Frame: 24 months after enrollment ] Febuxstat, allopurinol,or benzbromarone |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA） | ||
| 正式标题 ICMJE | The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA): A Prospective Cohort Study | ||
| 简要概况 | 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 .We therefore evaluated the renal effects of long-term aspirin (100 mg/d) administration in Chinese patients with coronary artery disease or other CVDs. |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
2000 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 1, 2022 | ||
| 预计主要完成日期 | November 1, 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. 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 desending, left circumflex or right coronary artery) , manifesting clinically as latent CAD, stable CAD, unstable CAD, and acute myocardial infarction. 2. Patients with CAD without PCI therapy. They document angiographically at least one vessel stenosis ≥50% among major coronary arteries (left main, left anterior desending, left circumflex or right coronary artery) , and classified clinically as latent CAD, stable CAD, unstable CAD. 3. Patients without CAD who needs antiplatlet therapy for prophylaxis of ASCVD, documenting angiographically no vessel stenosis ≥50% among any of major coronary arteries (left main, left anterior desending, left circumflex or right coronary artery). Exclusion Criteria: 1、Patients with severe conditions with life expectancy less than 12 months 2、Patients with malignant tumor 3、Severe Kidney disease: patients with acute kidney injury, nephritic syndrome, renal replacement therapy, kidney transplant or eGFR <30 mL/min/1.73 m2 4、Contraindicated to antiplatelet therapy because of acute bleeding 5、Patients who formerly administrated aspirin for at least one week or withdrawal of aspirin less than one month before enrollment 6、Patients who formerly administrated UA lowering agents at least one month before enrollment 7、Patients who formerly administrated, stopped or titrated doses of any of the following drugs at least one month before enrollment: losartan, urbesartan, fenofibrate, thiazide and loop diuretics 8、Patients who administrated ticagrelor as antiplatelet agent one month before enrollment or eversince. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：80 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Junbo Ge，Shanghai Zhongshan Hospital | ||
| 研究赞助商 ICMJE | Shanghai Zhongshan Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Shanghai Zhongshan Hospital | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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