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

Email

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/

Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name