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

Coronary Artery Disease Clinical Trial

— AURORA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691688
• Other study ID #: ZS-AURORA
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Shalaimaiti Shali, MD
• Phone: +86-13761553110
• Email: shali[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hyperuricemia
• Myocardial Ischemia

Intervention

Drug:
• Aspirin 100 mg
Aspirin 100mg will be prescribed for antiplatelet therapy at the physician`s discretion
• Clopidogrel 75mg
Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician`s discretion

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gout attacks (ACR/EULAR classification criteria 2015)	Gout attacks are confirmed according to ACR/EULAR classification criteria 2015	24 months after enrollment
Primary	Initiation of UA-lowering agents	Starting febuxostat, allopurinol,or benzbromarone therapy at physicians` descretion	24 months after enrollment
Secondary	Renal impairment (serum creatine level, µmol/L)	2-fold elevation of serum creatine level from baseline	24 months after enrollment