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

• ClinicalTrials.gov Identifier: NCT03691688
• Recruitment Status: Unknown
• First Posted: October 2, 2018
• Last Update Posted: November 29, 2018
• Sponsor: Shanghai Zhongshan Hospital
• Information provided by (Responsible Party): Junbo Ge, Shanghai Zhongshan Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Coronary Artery Disease; Hyperuricemia	Drug: Aspirin 100 mg; Drug: Clopidogrel 75mg

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• 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
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: November 1, 2021
• Estimated Study Completion Date: March 1, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. HUA ( serum uric acid level, μmol/L) [ Time Frame: 24 months after enrollment ]
   Two different days of fasting uric acid >420 μmol/L and women >360 μmol/L under normal purine diet.
2. Gout attacks (ACR/EULAR classification criteria 2015) [ Time Frame: 24 months after enrollment ]
   Gout attacks are confirmed according to ACR/EULAR classification criteria 2015
3. Initiation of UA-lowering agents [ Time Frame: 24 months after enrollment ]
   Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion

Secondary Outcome Measures :

1. Renal impairment (serum creatine level, μmol/L) [ Time Frame: 24 months after enrollment ]
   2-fold elevation of serum creatine level from baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: 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.

Criteria

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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Contacts and Locations

Contacts

Contact: Shalaimaiti Shali, MD; +86-13761553110; shali@zs-hospital.sh.cn

Contact: Yuxiang Dai, MD; +86-13818988550; dai.yuxiang@zs-hospital.sh.cn

Locations

China, Shanghai

Shanghai Zhongshan Hospital; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Shalaimaiti Shali, MD 86+13761553110 shali@zs-hospital.sh.cn

Contact: Yuxiang Dai, MD,PhD +86-13818988550 dai.yuxiang@zs-hospital.sh.cn

Principal Investigator: Junbo Ge, Professor

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

• Study Chair: Junbo Ge, MD; Fudan University

More Information

Additional Information:

• Responsible Party: Junbo Ge, Chief of Cardiology Department, Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT03691688
• Other Study ID Numbers: ZS-AURORA
• First Posted: October 2, 2018
• Last Update Posted: November 29, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Junbo Ge, Shanghai Zhongshan Hospital:

aspirin; coronary artery disease, uric acid

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperuricemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Aspirin; Clopidogrel; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists