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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014132
Receipt No. R000016062
Scientific Title A Key prospective surveillAnce study oF venoUs thromboembolism for Japanese patIents
Date of disclosure of the study information 2014/05/31
Last modified on 2020/12/04

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Basic information
Public title A Key prospective surveillAnce study oF venoUs thromboembolism for Japanese patIents
Acronym AKAFUJI study
Scientific Title A Key prospective surveillAnce study oF venoUs thromboembolism for Japanese patIents
Scientific Title:Acronym AKAFUJI study
Region
Japan

Condition
Condition venous thromboembolism
Classification by specialty
Cardiology Pneumology Vascular surgery
Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective observational study is to clarify the effect of conventional treatment and long-term prognosis of venous thromboembolism in Japanese.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of recurrence of symptomatic venous thromboembolism and hemorrhagic adverse events up to 52 weeks after diagnosis
Key secondary outcomes 1) Recurrence of symptomatic venous thromboembolism
2) Incidence of hemorrhagic adverse events
3) Background factors of venous thromboembolism
4) Effect and complication of treatment, and recurrence of symptomatic acute pulmonary thromboembolism,
5) Effect and complication of treatment, and recurrence of proximal deep vein thrombosis
6) Effect and complication of treatment, and recurrence of calf limited deep vein thrombosis
7) Adverse events other than bleeding event related to treatment of venous thromboembolism

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese males and females who meet following criterion either (1) or (2).
(1) Persons with episode of acute symptomatic pulmonary thromboembolism that thromboemboli are detected in pulmonary arteries by imaging and that corresponding symptoms are confirmed, and persons with episode of acute proximal deep vein thrombosis that new thrombi are detected in proximal deep veins by imaging whether corresponding symptom is confirmed or not.
(2) Persons with episode of acute isolated calf deep vein thrombosis that new thrombi are detected only in calf deep veins by imaging whether corresponding symptom is confirmed or not.
Key exclusion criteria (1) Persons who are initiated or planed a new oral anticoagulant therapy
(2) Persons who are ruled unfit to participate in this study by investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Mashio
Middle name
Last name Nakamura
Organization Mie University Graduate School of Medicine
Division name Department of Cardiovascular Research
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5015
Email mashio@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Norikazu
Middle name
Last name Yamada
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-5015
Homepage URL
Email n-yamada@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Clinical Research Support Center, Mie University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, Mie University Hospital
Address 2-174, Edobashi, Tsu, Mie
Tel 059-231-5045
Email kk-sien@mo.medic.mie-u.ac.jp

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 三重大学医学部附属病院(三重県),我汝会えにわ病院(北海道),熊本医療センター(熊本県),平塚共済病院(神奈川県),佐野厚生総合病院(栃木県),浜松医療センター(静岡県),長崎大学病院(長崎県),東名厚木病院(神奈川県),西宮市立中央病院(兵庫県),京都医療センター(京都府),かみいち総合病院(富山県),浜松赤十字病院(静岡県),東京医科大学八王子医療センター(東京都),武蔵野赤十字病院(東京都),福島県立医科大学附属病院(福島県),京都市立病院(京都府),JR仙台病院(宮城県),獨協医科大学日光医療センター(栃木県),国際医療福祉大学病院(栃木県),愛知医科大学病院(愛知県),大阪府立成人病センター(大阪府),埼玉医科大学総合医療センター(埼玉県),愛媛大学病院(愛媛県),日本大学医学部附属板橋病院(東京都),横浜南共済病院(神奈川県),埼玉医科大学病院(埼玉県),浜松医科大学病院(静岡県),久留米大学病院(福岡県),長崎医療センター(長崎県),東海大学病院(神奈川県),東邦大学医療センター佐倉病院(千葉県),岡山医療センター(岡山県),横浜市立大学附属市民総合医療センター(神奈川県),熊本大学医学部附属病院(熊本県),宗像水光会総合病院(福岡県),東海大学医学部付属八王子病院(東京都),熊本病院(熊本県),東北大学病院(宮城県),自治医科大学附属病院(栃木県),千葉大学医学部附属病院(千葉県),奈良県立医科大学附属病院(奈良県),山形済生病院(山形県),小倉記念病院(福岡県),名古屋第一赤十字病院(愛知県),北里大学病院(神奈川県),日本医科大学付属病院(東京都),金沢医科大学病院(石川県),名古屋市立大学病院(愛知県),聖隷三方原病院(静岡県),村瀬病院(三重県),徳島大学病院(徳島県),杏林大学医学部付属病院(東京都),横浜市南部病院(神奈川県),関西医科大学附属滝井病院(大阪府),山形大学医学部附属病院(山形県),国立循環器病研究センター(大阪府),広島大学病院(広島県),杏林大学医学部付属病院(東京都),大阪医療センター(大阪府),藤田保健衛生大学病院(愛知県),東京医科大学病院(東京都),獨協医科大学病院(栃木県)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 05 Month 25 Day
Date of IRB
2014 Year 05 Month 30 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 11 Month 30 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information We conduct a prospective observational study of (de novo) 1000 Japanese VTE patients to evaluate associations between "background factors and treatment" and "recurrence rate of symptomatic VTE and incidence of hemorrhagic and other adverse events".

Management information
Registered date
2014 Year 05 Month 31 Day
Last modified on
2020 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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