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Table 1 Detailed inclusion and exclusion criteria

From: Rationale and design of a multicenter randomized study for evaluating vascular function under uric acid control using the xanthine oxidase inhibitor, febuxostat: the PRIZE study

Inclusion

Exclusion

Adults (aged ≥20 years)

Patients with asymptomatic hyperuricemia with a serum UA >7.0 mg/dL

Patients with a maximum IMT ≥1.1 mm

The patient provided written informed consent to participate in the study

Patients being treated with any of the following antihyperuricemic agents within 8 weeks before confirmation of the eligibility criteria: allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat

Patients being treated with any of the following agents at the time of confirmation of the eligibility criteria: mercaptopurine hydrate, azathioprine, vidarabine, or didanosine

Patients who have undergone an operation or who have severe infections or serious injury at the time of confirmation of the eligibility criteria.

Patients who had a myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty/bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient cerebral ischemic attack within 3 months before confirmation of the eligibility criteria

Patients with cardiac dysfunction (NYHA class IV)

Patients with gouty tophus, or those who have subjective symptoms of gout arthritis within 1 year before confirmation of the eligibility criteria

Patients with a complication or a disease history (eGFR <30 mL/min/1.73 m2 or patients on dialysis)

Patients with severe liver dysfunction (AST or ALT ≥2 times the upper limit of the institutional standard value)

Patients with a complication or a disease history (e.g. malignant tumor) who are considered not eligible for the study by the attending doctor

Patients with a history of hypersensitivity to febuxostat

Pregnant, possibly pregnant, or lactating women or those who wish to become pregnant during participation in the study

Patients who have undergone CEA or CAS surgery

Patients who are considered not eligible for the study by the attending doctor due to other reasons

  1. ALT alanine aminotransferase, AST aspartate transaminase, CAS carotid artery stenting, CEA carotid endarterectomy, eGFR estimated glomerular filtration rate, IMT intima-media thickness, NYHA New York Heart Association, UA uric acid