UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000012911 |
| Receipt No. | R000015081 |
| Scientific Title | Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study |
| Date of disclosure of the study information | 2014/01/22 |
| Last modified on | 2020/08/11 (Ver. 16) |
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| Basic information | ||
| Public title | Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study | |
| Acronym | PRIZE study | |
| Scientific Title | Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study | |
| Scientific Title:Acronym | PRIZE study | |
| Region |
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| Condition | ||||||
| Condition | Hyperuricemia | |||||
| Classification by specialty |
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| Classification by malignancy | Others | |||||
| Genomic information | NO | |||||
| Objectives | |
| Narrative objectives1 | To evaluate the effect of prevention of progress of atherosclerosis by uric acid lowering therapy with febuxostat in patients with hyperuricemia using carotid intima-media thickness (IMT) as an indicator |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Percentage change in the mean IMT of common carotid artery after 24 months from baseline as measured by carotid ultrasound imaging |
| Key secondary outcomes | 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 |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | |
| Blinding | Open -but assessor(s) are blinded |
| Control | Active |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | Central registration |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Febuxostat group
(patients receiving febuxostat) |
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| Interventions/Control_2 | Control group
(patients not receiving febuxostat) |
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| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key 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 |
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| Key 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 |
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| Target sample size | 500 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Saga University | ||||||
| Division name | Department of Cardiovascular Medicine | ||||||
| Zip code | |||||||
| Address | 5-1-1 Nabeshima, Saga-shi, Saga | ||||||
| TEL | 0952-34-2364 | ||||||
| node@cc.saga-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Nouvelle Place Inc. | ||||||
| Division name | Research Management Office | ||||||
| Zip code | |||||||
| Address | 4-1-28, Toranomon, Minato-ku, Tokyo, Japan 105- 0001 | ||||||
| TEL | 03-6680-2525 | ||||||
| Homepage URL | https://ncsg.jp/prize/ | ||||||
| prize@n-place.co.jp | |||||||
| Sponsor | |
| Institute | Department of Cardiovascular Medicine, Saga University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | TEIJIN PHARMA LIMITED |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | Department of Cardiology, Nagoya University
Department of Cardiovascular Medicine, Dokkyo Medical University Department of Cardiovascular Medicine and Hypertension, Kagoshima University Department of Clinical Cell Biology and Medicine, Chiba University Division of Cardiovascular Medicine, Jichi Medical University Department of Metabolism and Endocrinology, Juntendo University Department of Cardiovascular Medicine, Juntendo University, Graduate School of Medicine Department of Neurology, Tokyo Women's Medical University Department of Endocrinology and Metabolism, Osaka University Diabetes Therapeutics and Research Center, The University of Tokushima Division of Cardiovascular Medicine, Kurume University Department of Cardiovascular Medicine, Nagasaki University Department of Cardiovascular Medicine, Nephrology and Neurology, University of the Ryukyus Research institute for Radiation Biology and Medicine, Hiroshima University Second Department of Internal Medicine, Tokyo Medical University Department of Cardiovascular Medicine / Clinical Laboratory, Tsukuba University Department of Cardiovascular Medicine / Ultrasound Examination Center, The University of Tokushima Department of Cardio-angiology, Kitasato University Department of Cardiovascular Medicine, Nippon Medical School Department of Cardiovascular Medicine, Chiba University Division of Cardiovascular Medicine and Coronary Heart Disease, Hyogo College of Medicine Clinical Research Center, Chiba University Hospital Clinical Research Center, University of the Ryukyus Hospital |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | |
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| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 佐賀大学医学部附属病院（佐賀県）、名古屋大学医学部附属病院（愛知県）、獨協医科大学病院（栃木県）、徳島大学病院（徳島県）、鹿児島大学病院（鹿児島県）、千葉大学医学部附属病院（千葉県）、自治医科大学附属病院（栃木県）、久留米大学病院（福岡県）、長崎大学病院（長崎県）、北里大学病院（神奈川県）、広島大学病院（広島県）、東京医科大学病院（東京都）、筑波大学附属病院（茨城県）、日本医科大学附属病院（千葉県）、国立病院機構 栃木医療センター（栃木県）、宮崎市郡医師会病院（宮崎県）、国立病院機構霞ヶ浦医療センター（茨城県）、西尾市民病院（愛知県）、岐阜県立多治見病院（岐阜県）、佐賀県医療センター好生館（佐賀県）、名古屋掖済会病院（愛知県）、国際医療福祉大学病院（栃木県）、国立病院機構鹿児島医療センター（鹿児島県）、名古屋第一赤十字病院（愛知県）、防衛医科大学校病院（埼玉県）、鹿児島市立病院（鹿児島県）、野崎徳洲会総合病院（大阪府）、JR広島病院（広島県）、名古屋第二赤十字病院（愛知県）、獨協医科大学埼玉医療センター（埼玉県）、福岡県済生会二日市病院（福岡県）、安城更生病院（愛知県）、朝日生命成人病研究所附属医院（東京都）、亀田総合病院（千葉県）、総合病院国保旭中央病院（千葉県）、千葉市立青葉病院（千葉県）、伊万里有田共立病院（佐賀県）、大阪医科大学附属病（大阪府）、佐世保市総合医療センター（長崎県）、関野病院（東京都）、横田内科（宮崎県）、君津中央病院（千葉県）、ニコ―クリニック（佐賀県）、いすみ医療センター（千葉県）、ほたるのセントラル内科（千葉県）、春日井市民病院（愛知県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003095#sec027 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003095 | ||||||
| Number of participants that the trial has enrolled | 514 | ||||||
| Results | Preparing for update. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Preparing for update. |
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| Participant flow | Preparing for update. |
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| Adverse events | Preparing for update. |
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| Outcome measures | Preparing for update. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | None |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015081 |
