Authors
»
[No authors listed]
Category
»
Primary study
Registry of Trials»UMIN Clinical Trials Registry
Year
»
2014
INTERVENTION: Febuxostat group (patients receiving febuxostat) Control group (patients not receiving febuxostat) CONDITION: Hyperuricemia PRIMARY OUTCOME: Percentage change in the mean IMT of common carotid artery after 24 months from baseline as measured by carotid ultrasound imaging SECONDARY OUTCOME: 1) The following values measured by carotid ultrasound imaging (common carotid artery, bulbus, internal carotid artery) at baseline, after 12 months, and after 24 months, and the amount of change and %change from baseline (excluding the %change in the mean IMT of common carotid artery after 24 months from baseline, which is the primary endpoint) ; ; The mean IMT, the maximum IMT, plaque area, plaque echogenicity; ; 2) Serum uric acid levels at baseline, after 6 months, 12 months, and 24 months, and the amount of change and %change from baseline; ; 3) Values of the following clinical parameters at baseline, after 6 months, 12 months, and 24 months, and the amount of change and %change from baseline; ; Serum lipids [TC, HDL‐C, TG, LDL‐C (indirect method), non‐HDL‐C], serum creatinine, eGFR, urinary albumin excretion (creatinine corrected value) [in patients with a complication of diabetes mellitus], urinary L‐FABP (in patients with a complication of diabetes or CKD); ; 4) Values of the following clinical parameters and cardiovascular function parameters at baseline, after 12 months, and 24 months, and the amount of change and %change from baseline.; ; NT‐proBNP, blood pressure (office) ; ; 5) The following events that occurred from baseline until after 24 months or study discontinuation ; ; Composite events (cardiovascular death, non‐fatal myocardial infarction and stroke, renal events, all‐cause death) and incidence of each event; ; 6) Adverse events that occurred from baseline until after 24 months or study discontinuation INCLUSION CRITERIA: 1) Patients aged >=20 years at the time informed consent is obtained (both sexes) 2) Patients with asymptomatic hyperuricemia with serum uric acid >7.0 mg/dL 3) Patients with the maximum IMT >=1.1 mm 4) Patients who gave written informed consent to participate in the study
Epistemonikos ID: 49e94d05197b94a59c7771ba295fbd634d08a04f
First added on: Aug 23, 2024