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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Hyperuricemia
• Intervention / Treatment: Drug: Aspirin 100 mg; Drug: Clopidogrel 75mg

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Shalaimaiti Shali, MD; Phone Number: +86-13761553110; Email: shali@zs-hospital.sh.cn
• Study Contact Backup: Name: Yuxiang Dai, MD; Phone Number: +86-13818988550; Email: dai.yuxiang@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
      • Principal Investigator: Junbo Ge, Professor
      • Contact: Shalaimaiti Shali, MD; Phone Number: 86+13761553110; Email: shali@zs-hospital.sh.cn
      • Contact: Yuxiang Dai, MD,PhD; Phone Number: +86-13818988550; Email: dai.yuxiang@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aspirin; Aspirin 100mg	Drug: Aspirin 100 mg; Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion
Clopidogrel; Clopidogrel 75mg	Drug: Clopidogrel 75mg; Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gout attacks (ACR/EULAR classification criteria 2015)	Gout attacks are confirmed according to ACR/EULAR classification criteria 2015	24 months after enrollment
Initiation of UA-lowering agents	Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion	24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal impairment (serum creatine level, μmol/L)	2-fold elevation of serum creatine level from baseline	24 months after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: aspirin; coronary artery disease, uric acid
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperuricemia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: ZS-AURORA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No