UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012911 |
|---|---|
| Receipt number | 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 10:24:57 |
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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
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics |
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
| Medicine |
Interventions/Control_1
Febuxostat group
(patients receiving febuxostat)
Interventions/Control_2
Control group
(patients not receiving febuxostat)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
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
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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Node |
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
| 1st name | |
| Middle name | |
| Last name | Itsuka Suzuki |
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 or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
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
Address
Tel
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
| 2014 | Year | 01 | Month | 22 | Day |
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.
Results date posted
| 2020 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Preparing for update.
Participant flow
Preparing for update.
Adverse events
Preparing for update.
Outcome measures
Preparing for update.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 12 | Day |
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015081
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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