Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study

Conditions

Hyperuricemia

Saito Y, Tanaka A, Ishizu T, Yoshida H, Kubota Y, Nanasato M, Matsuhisa M, Ohya Y, Kobayashi Y, Node K, PRIZE Study Investigators.

2023-07-051 citations

10.1038/s41598-023-37183-0

Impact of febuxostat on visit-to-visit blood pressure variability: insights from the randomised PRIZE Study

Yuichi Saito, Atsushi Tanaka, Yuji Koide, Hisako Yoshida, Daigaku Uchida et al. (10 authors)

RMD Open2022-09-011 citations

10.1136/rmdopen-2022-002505

Association between serum urate level and carotid atherosclerosis: an insight from a post hoc analysis of the PRIZE randomised clinical trial

Atsushi Tanaka, Shigeru Toyoda, Toru Kato, Hisako Yoshida, Shuichi Hamasaki et al. (10 authors)

RMD Open2022-04-018 citations

10.1136/rmdopen-2022-002226

Febuxostat does not delay progression of carotid atherosclerosis in patients with asymptomatic hyperuricemia: A randomized, controlled trial

Atsushi Tanaka, Isao Taguchi, Hiroki Teragawa, Nobukazu Ishizaka, Yumiko Kanzaki et al. (24 authors)

PLoS Medicine2020-04-2298 citations

10.1371/journal.pmed.1003095

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.

Oyama J, Tanaka A, Sato Y, Tomiyama H, Sata M, Ishizu T, Taguchi I, Kuroyanagi T, Teragawa H, Ishizaka N, Kanzaki Y, Ohishi M, Eguchi K, Higashi Y, Yamada H, Maemura K, Ako J, Bando YK, Ueda S, Inoue T, Murohara T, Node K, PRIZE Study Investigators.

2016-06-1829 citations

10.1186/s12933-016-0409-2

Interventions

Febuxostat group (patients receiving febuxostat) Control group (patients not receiving febuxostat)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1) Patients being treated with any of the following antihyperuricemic agents within 8 weeks before confirmation of the eligibility criteria: Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, febuxostat 2) Patients being treated with any of the following agents at the time of confirmation of the eligibility criteria: Mercaptopurine hydrate, azathioprine, vidarabine, didanosine 3) Patients who have undergone an operation or who have severe infections or serious injury at the time of confirmation of the eligibility criteria 4) Patients who had 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 5) Patients with cardiac dysfunction (NYHA class IV) 6) Patients with gouty tophus, or those who have subjective symptoms of gout arthritis within 1 year before confirmation of the eligibility criteria 7) Patients with severe renal dysfunction (eGFR <30 mL/min or patients under dialysis) 8) Patients with severe liver dysfunction (AST or ALT <=2 times the upper limit of the institutional standard value) 9) Patients with a complication or a disease history (e.g. malignant tumor) who are considered not eligible for the study by the attending doctor 10) Patients with a history of hypersensitivity to febuxostat 11) Pregnant, possibly pregnant, or lactating women or those who wish to become pregnant during participation in the study 12)Patients who underwent CEA or CAS surgery 13) Patients who are considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

Measure	Time frame
Percentage change in the mean IMT of common carotid artery after 24 months from baseline as measured by carotid ultrasound imaging	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactItsuka Suzuki

Nouvelle Place Inc. Research Management Office

prize@n-place.co.jp03-6680-2525

Outcome results

None listed