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

• Conditions: Coronary Artery Disease; Hyperuricemia
• Interventions: Drug: Aspirin 100 mg; Drug: Clopidogrel 75mg

• Registration Number: NCT03691688
• Lead Sponsor: Shanghai Zhongshan Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29
• Study Start: 2018-12-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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 descending, 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 descending, left circumflex or right coronary artery) , and classified clinically as latent CAD, stable CAD, unstable CAD.
3. 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

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, irbesartan, fenofibrate, thiazide and loop diuretics.

8. Patients who administrated ticagrelor as antiplatelet agent one month before enrollment or since then.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin 100 mg	Aspirin 100mg
Clopidogrel	Clopidogrel 75mg	Clopidogrel 75mg

Primary Outcome Measures

Name	Time	Method
HUA ( serum uric acid level, μmol/L)	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	24 months after enrollment	Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion
Gout attacks (ACR/EULAR classification criteria 2015)	24 months after enrollment	Gout attacks are confirmed according to ACR/EULAR classification criteria 2015

Secondary Outcome Measures

Name	Time	Method
Renal impairment (serum creatine level, μmol/L)	24 months after enrollment	2-fold elevation of serum creatine level from baseline

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China