Coronary Artery DiseaseAURORANCT03691688
The Long Term Effect of Low Dose Aspirin on Uric Acid in Chinese Patients With Coronary Artery Disease（AURORA）
An observational study of Coronary Artery Disease and Hyperuricemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Hyperuricemia
- What is being tested?
- Aspirin 100 mg and Clopidogrel 75mg
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Mar 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
- 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).
Who cannot join
- Patients with severe conditions with life expectancy less than 12 months.
- Patients with malignant tumor.
- Severe Kidney disease: patients with acute kidney injury, nephritic syndrome, renal replacement therapy, kidney transplant or eGFR <30 mL/min/1.73 m2.
- Contraindicated to antiplatelet therapy because of acute bleeding.
- Patients who formerly administrated aspirin for at least one week or withdrawal of aspirin less than one month before enrollment.
- Patients who formerly administrated UA lowering agents at least one month before enrollment.
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- 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.
- Patients who administrated ticagrelor as antiplatelet agent one month before enrollment or since then.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Shalaimaiti Shali, MD, 86+13761553110, shali@zs-hospital.sh.cn
Yuxiang Dai, MD,PhD, +86-13818988550, dai.yuxiang@zs-hospital.sh.cn
About this study
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
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.
- Conditions
- Coronary Artery Disease, Hyperuricemia
- Being tested
- Aspirin 100 mg, Clopidogrel 75mg
- Keywords
- aspirin; coronary artery disease, uric acid
- Medical subject headings
- Coronary Artery Disease, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100 mgDrug
Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion
Clopidogrel 75mgDrug
Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Aspirin 100mg Receives: Drug: Aspirin 100 mg | |
| Clopidogrel | Clopidogrel 75mg Receives: Drug: Clopidogrel 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after enrollment
Gout attacks (ACR/EULAR classification criteria 2015)
Gout attacks are confirmed according to ACR/EULAR classification criteria 2015
Measured: 24 months after enrollment
Initiation of UA-lowering agents
Starting febuxostat, allopurinol,or benzbromarone therapy at physicians' descretion
Measured: 24 months after enrollment
Secondary outcomes (1)
Renal impairment (serum creatine level, μmol/L)
2-fold elevation of serum creatine level from baseline
Measured: 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Junbo Ge, MD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691688
- Sponsor's protocol ID
- ZS-AURORA
- Acronym
- AURORA
- Status last verified
- Nov 2018
- First submitted
- 28 Sep 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03691688
- Acronym / sponsor ID
- AURORA / ZS-AURORA
- Conditions
- Coronary Artery Disease, Hyperuricemia
- Keywords
- aspirin; coronary artery disease, uric acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | – | Drug: Aspirin 100 mgAspirin 100mg |
| Clopidogrel | – | Drug: Clopidogrel 75mgClopidogrel 75mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- 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.
- 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).
Key exclusion criteria (9 listed)
- Patients with severe conditions with life expectancy less than 12 months.
- Patients with malignant tumor.
- Severe Kidney disease: patients with acute kidney injury, nephritic syndrome, renal replacement therapy, kidney transplant or eGFR <30 mL/min/1.73 m2.
- Contraindicated to antiplatelet therapy because of acute bleeding.
- Patients who formerly administrated aspirin for at least one week or withdrawal of aspirin less than one month before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 100 mgAspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion | Drug | Aspirin |
| Clopidogrel 75mgClopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion | Drug | Clopidogrel |
Primary outcome
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
1 secondary outcome
Renal impairment (serum creatine level, μmol/L)
Time frame: 24 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, MD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Hyperuricemia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shalaimaiti Shali, MD (+86-13761553110, shali@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HUA ( serum uric acid level, μmol/L) (time frame: 24 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.