UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014132 |
|---|---|
| Receipt number | 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 | 2024/06/10 14:42:10 |
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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
Hidamarinooka Nakamura Medical Clinic
Division name
Department of Internal Medicine, Pediatrics and Cardiology
Zip code
511-0867
Address
7-1510, Hidamarinooka, Kuwana, Mie Japan
TEL
0594-33-1616
nakamura@hidamari-naika.jp
Public contact
Name of contact person
| 1st name | Norikazu |
| Middle name | |
| Last name | Yamada |
Organization
Kuwana City Medical Center
Division name
Department of Cardiology
Zip code
511-0061
Address
3-11, Kotobukicho, Kuwana, Mie Japan
TEL
0594-22-1211
Homepage URL
n-yamada@kuwanacmc.or.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/circj/88/3/88_CJ-23-0158/_pdf/-char/en
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/88/3/88_CJ-23-0158/_pdf/-char/en
Number of participants that the trial has enrolled
352
Results
The cumulative incidence of recurrent symptomatic VTE was higher in patients without warfarin than in those treated with warfarin (8.7 vs. 2.2 per 100 person-years, respectively; P=0.018).
Results date posted
| 2024 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
Eligible patients were those diagnosed with acute symptomatic PE and acute symptomatic/asymptomatic DVT, including isolated distal DVT by imaging techniques, and for whom DOAC had not been prescribed within the study period. All patients provided written informed consent before registration.
Participant flow
The AKAFUJI study was a multicenter prospective observational cohort study designed to obtain real-world evidence of clinical outcomes in Japanese patients with acute symptomatic/asymptomatic VTE (deep vein thrombosis [DVT], pulmonary thromboembolism [PE], or both) treated with warfarin in real-world clinical practice and followed-up for 1 year after diagnosis; the target number of patients was 1,000.
Adverse events
The cumulative incidence of bleeding complications was not significantly different between the 2 groups (4.0 vs. 1.8 per 100 person-years for warfarin on-treatment vs. without warfarin, respectively; P=0.434).
Outcome measures
The cumulative incidence of recurrent symptomatic VTE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016062
