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

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

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

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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

Resource links provided by the National Library of Medicine


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




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



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691688


Contacts
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Contact: Shalaimaiti Shali, MD +86-13761553110 shali@zs-hospital.sh.cn
Contact: Yuxiang Dai, MD +86-13818988550 dai.yuxiang@zs-hospital.sh.cn

Locations
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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
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Study Chair: Junbo Ge, MD Fudan University

Additional Information:

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Responsible Party: Junbo Ge, Chief of Cardiology Department, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03691688     History of Changes
Other Study ID Numbers: ZS-AURORA
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperuricemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Aspirin
Clopidogrel
Uric Acid
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
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists