The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA）

Study Overview
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Brief Summary
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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.

Official Title
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The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA): A Prospective Cohort Study

Conditions
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Coronary Artery Disease, Hyperuricemia

Intervention / Treatment
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* Drug: Aspirin 100 mg
* Drug: Clopidogrel 75mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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 m2. 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspirin<br>Aspirin 100mg | Drug: Aspirin 100 mg<br>* Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion<br>|
| Clopidogrel<br>Clopidogrel 75mg | Drug: Clopidogrel 75mg<br>* Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HUA ( serum uric acid level, μmol/L) | Two different days of fasting uric acid >420 μmol/L and women >360 μmol/L under normal purine diet. | 24 months after enrollment | 
| Gout attacks (ACR/EULAR classification criteria 2015) | Gout attacks are confirmed according to ACR/EULAR classification criteria 2015 | 24 months after enrollment | 
| Initiation of UA-lowering agents | Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal impairment (serum creatine level, μmol/L) | 2-fold elevation of serum creatine level from baseline | 24 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin; coronary artery disease, uric acid