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Status unknownNCT03691688AURORAUpdated Nov 29, 2018

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

An observational study in Coronary Artery Disease and Hyperuricemia, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-29.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
  • Hyperuricemia

Keywords

  • aspirin; coronary artery disease, uric acid
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Study population consists of angiographically diagnosised CAD patients with or without PCI, and patients without CAD who needs antiplatlet therapy for prophylaxis of ASCVD.

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

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.

    -

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Aspirin

    Aspirin 100mg

    Drug: Aspirin 100 mg

  • Clopidogrel

    Clopidogrel 75mg

    Drug: Clopidogrel 75mg

Interventions

  • DrugAspirin 100 mg

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months after enrollment

  2. Gout attacks (ACR/EULAR classification criteria 2015)

    Gout attacks are confirmed according to ACR/EULAR classification criteria 2015

    Time frame: 24 months after enrollment

  3. Initiation of UA-lowering agents

    Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion

    Time frame: 24 months after enrollment

Secondary outcomes

  1. Renal impairment (serum creatine level, μmol/L)

    2-fold elevation of serum creatine level from baseline

    Time frame: 24 months after enrollment

07

Study locations

1 of 1 sites recruiting
  • Shanghai Zhongshan Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03691688
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Junbo Ge (Chief of Cardiology Department, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Oct 2, 2018
Start date
Dec 1, 2018 (estimated)
Primary completion
Nov 1, 2021 (estimated)
Completion
Mar 1, 2022 (estimated)
Last update
Nov 29, 2018

Study contacts

Shalaimaiti Shali, MD
Contact
shali@zs-hospital.sh.cn
+86-13761553110
Yuxiang Dai, MD
Contact
dai.yuxiang@zs-hospital.sh.cn
+86-13818988550
Junbo Ge, MD
study chair · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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