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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Aspirin 100mg |
| |
| Clopidogrel | Clopidogrel 75mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 100 mg | Drug | Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal impairment (serum creatine level, μmol/L) | 2-fold elevation of serum creatine level from baseline | 24 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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Study population consists of angiographically diagnosised CAD patients with or without PCI, and patients without CAD who needs antiplatlet therapy for prophylaxis of ASCVD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shalaimaiti Shali, MD | Contact | +86-13761553110 | shali@zs-hospital.sh.cn | |
| Yuxiang Dai, MD | Contact | +86-13818988550 | dai.yuxiang@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, MD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Clopidogrel 75mg | Drug | Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |