The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA）
Sponsor:
Shanghai Zhongshan Hospital
Collaborators:
Information provided by (Responsible Party):
Junbo Ge，Shanghai Zhongshan Hospital
| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | November 1, 2018 | ||
| Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures 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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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA） |
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| Official Title ICMJE | The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA): A Prospective Cohort Study |
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| Brief Summary | 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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| Detailed Description | |||
| Study Type ICMJE | Observational [Patient Registry] | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational [Patient Registry] Masking Description: Primary Purpose: |
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| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
2000 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 1, 2022 | ||
| Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria 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. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Junbo Ge，Shanghai Zhongshan Hospital | ||
| Study Sponsor ICMJE | Shanghai Zhongshan Hospital | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Shanghai Zhongshan Hospital | ||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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