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Trial record 14 of 252 for:    ASPIRIN AND low-dose aspirin

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

Tracking Information
First Submitted Date September 28, 2018
First Posted Date October 2, 2018
Last Update Posted Date November 29, 2018
Estimated Study Start Date December 1, 2018
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2018)
  • 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.
  • Gout attacks (ACR/EULAR classification criteria 2015) [ Time Frame: 24 months after enrollment ]
    Gout attacks are confirmed according to ACR/EULAR classification criteria 2015
  • Initiation of UA-lowering agents [ Time Frame: 24 months after enrollment ]
    Starting febuxostat, allopurinol,or benzbromarone therapy at physicians` descretion
Original Primary Outcome Measures
 (submitted: September 28, 2018)
  • HUA [ Time Frame: 24 months after enrollment ]
    hyperuricemia
  • Gout attacks [ Time Frame: 24 months after enrollment ]
    ACR/EULAR classification criteria 2015
  • Initiation of UA-lowering agents [ Time Frame: 24 months after enrollment ]
    Febuxstat, allopurinol,or benzbromarone
Change History Complete list of historical versions of study NCT03691688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 7, 2018)
Renal impairment (serum creatine level, μmol/L) [ Time Frame: 24 months after enrollment ]
2-fold elevation of serum creatine level from baseline
Original Secondary Outcome Measures
 (submitted: September 28, 2018)
Renal impairment [ Time Frame: 24 months after enrollment ]
2-fold elevation of serum creatine level
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease(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
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
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.
Condition
  • Coronary Artery Disease
  • Hyperuricemia
Intervention
  • Drug: Aspirin 100 mg
    Aspirin 100mg will be prescribed for antiplatelet therapy at the physician`s discretion
  • Drug: Clopidogrel 75mg
    Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician`s discretion
Study Groups/Cohorts
  • Aspirin
    Aspirin 100mg
    Intervention: Drug: Aspirin 100 mg
  • Clopidogrel
    Clopidogrel 75mg
    Intervention: Drug: Clopidogrel 75mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2018)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2022
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

    -

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shalaimaiti Shali, MD +86-13761553110 shali@zs-hospital.sh.cn
Contact: Yuxiang Dai, MD +86-13818988550 dai.yuxiang@zs-hospital.sh.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03691688
Other Study ID Numbers ZS-AURORA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Junbo Ge, Shanghai Zhongshan Hospital
Study Sponsor Shanghai Zhongshan Hospital
Collaborators Not Provided
Investigators
Study Chair: Junbo Ge, MD Fudan University
PRS Account Shanghai Zhongshan Hospital
Verification Date November 2018