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

Fudan University

Status: Unknown

Conditions: Coronary Artery Disease; Hyperuricemia

Treatments: Drug: Clopidogrel 75mg; Drug: Aspirin 100 mg

Study type: Observational

Funder types: Other

Identifiers

NCT03691688

ZS-AURORA

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

Aspirin

Description:

Aspirin 100mg

Treatment:

Drug: Aspirin 100 mg

Clopidogrel

Description:

Clopidogrel 75mg

Treatment:

Drug: Clopidogrel 75mg