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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03691688
Acronym
AURORA
Enrollment
2000
Registered
2018-10-02
Start date
2018-12-01
Completion date
2022-03-01
Last updated
2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Hyperuricemia

Keywords

aspirin; coronary artery disease, uric acid

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.

Interventions

Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion

DRUGClopidogrel 75mg

Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
HUA ( serum uric acid level, μmol/L)24 months after enrollmentTwo different days of fasting uric acid \>420 μmol/L and women \>360 μmol/L under normal purine diet.
Gout attacks (ACR/EULAR classification criteria 2015)24 months after enrollmentGout attacks are confirmed according to ACR/EULAR classification criteria 2015
Initiation of UA-lowering agents24 months after enrollmentStarting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion

Secondary

MeasureTime frameDescription
Renal impairment (serum creatine level, μmol/L)24 months after enrollment2-fold elevation of serum creatine level from baseline

Countries

China

Contacts

Primary ContactShalaimaiti Shali, MD
shali@zs-hospital.sh.cn+86-13761553110
Backup ContactYuxiang Dai, MD
dai.yuxiang@zs-hospital.sh.cn+86-13818988550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026