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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023747
Receipt No. R000027361
Scientific Title Prospective study of non-vitamin K antagonist oral anticoagulants (NOACs) management in Japanese patients with deep vein thrombosis and pulmonary embolism (DVT/PE)
Date of disclosure of the study information 2016/08/25
Last modified on 2018/11/30

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Basic information
Public title Prospective study of non-vitamin K antagonist oral anticoagulants (NOACs) management in Japanese patients with deep vein thrombosis and pulmonary embolism (DVT/PE)
Acronym Prospective study on management of DVT and PE with NOACs (KUROSIO study)
Scientific Title Prospective study of non-vitamin K antagonist oral anticoagulants (NOACs) management in Japanese patients with deep vein thrombosis and pulmonary embolism (DVT/PE)
Scientific Title:Acronym Prospective study on management of DVT and PE with NOACs (KUROSIO study)
Region
Japan

Condition
Condition Venous thrombosis
Classification by specialty
Cardiology Pneumology Gastrointestinal surgery
Vascular surgery Obsterics and gynecology Orthopedics
Urology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective observational study is clarified the effect of NOACs treatment and long-term prognosis of venous thromboembolism in Japanese.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
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 at 52, 104 and 156 weeks
2) Incidence of hemorrhagic adverse events at 52, 104 and 156 weeks
3) Patient 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 isolated calf 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), and begin treatment with NOACs or take already.
(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 warfarin or other Vitamin K antagonists therapy
(2) Persons who are initiated or planed non-drug therapy
(3) Persons who are not applicable to participate in this study by investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mashio Nakamura
Organization Nakamura Medical Clinic
Division name Department of Internal Medicine, Pediatrics and Cardiology
Zip code
Address 7-1510, Hidamarinooka, Kuwana, Mie
TEL 0594-33-1616
Email mashio@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu Yamada
Organization Kuwana East Medical Center
Division name Department of Cardiology
Zip code
Address 3-11, Kotobukicho, Kuwana, Mie
TEL 0594-22-1211
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
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 三重大学医学部附属病院(三重県)、 村瀬病院(三重県)、 大阪府済生会千里病院(大阪府)、 加古川中央市民病院(兵庫県)、 浜松医療センター(静岡県)、 山形県立中央病院(山形県)、 岐阜県総合医療センター (岐阜県)、 日本大学医学部附属板橋病院(東京都)、 小倉記念病院(福岡県)、 東海大学医学部付属病院(神奈川県)、 京都医療センター(京都府)、 かみいち総合病院(富山県)、 製鉄記念室蘭病院(北海道)、 西宮市立中央病院(兵庫県)、 長崎大学病院(長崎県)、 武蔵野赤十字病院(東京都)、 JR広島病院(広島県)、 東北大学病院(宮城県)、 佐久総合病院佐久医療センター(長野県)、 金沢医科大学氷見市民病院(富山県)、 千葉県循環器病センター(千葉県)、 東名厚木病院(神奈川県)、 市立豊中病院(大阪府)、 杏林大学病院(東京都)、 岩手県立中央病院(岩手県)、 東邦大学医療センター大橋病院(東京都)、 久留米大学病院(福岡県)、 藤沢市民病院(神奈川県)、 昭和大学藤が丘病院(神奈川県)、 国際医療福祉大学病院(栃木県)、 徳島大学病院(徳島県)、 浜松医科大学附属病院(静岡県)、 済生会熊本病院(熊本県)、 東京都立多摩総合医療センター(東京都)、 京都大学病院(京都府)、 横浜労災病院(神奈川県)、 群馬県立心臓血管センター(群馬県)、 獨協医科大学日光医療センター(栃木県)、 東京女子医科大学(東京都)、 横浜南共済病院(神奈川県)、 福井大学附属病院(福井県)、 済生会和歌山病院(和歌山)、 北海道大学病院(北海道)、 愛知医科大学病院(愛知県)、 東京医科大学病院(東京都)、 北野病院(大阪府)、 倉敷中央病院(岡山県)、 熊本大学医学部附属病院(熊本県)、 筑波大学病院(茨城県)、 福島県立医科大学病院(福島県)、 横浜医療センター(神奈川県)、 東邦大学医療センター佐倉病院(千葉県)、 横浜市立大学附属市民総合医療センター(神奈川県)、 日本医科大学付属病院(東京都)、 済生会横浜市南部病院(神奈川県)、 大阪国際がんセンター(大阪府)、 奈良県立医科大学附属病院(奈良県)、 岡山医療センター(岡山県)、 高知大学病院(高知県)、 福岡県済生会八幡総合病院(福岡県)、 大阪医療センター(大阪府)、 東海大学医学部付属八王子病院(東京都)、 名古屋第二赤十字病院 (愛知県)、 長崎医療センター(長崎県)、 イムス富士見総合病院(埼玉県)、 弘前大学医学部附属病院(青森県)、 関西医科大学総合医療センター(大阪府)、 藤田保健衛生大学病院(愛知県)、 国立循環器病研究センター(大阪府)、 国際医療福祉大学三田病院(東京都)、 広島赤十字原爆病院(広島県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 25 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
2016 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 05 Month 31 Day

Other
Other related information Prospective observational study
Recurrence rate of symptomatic venous thromboembolism
Incidence rate of hemorrhagic adverse events
Background factors of venous thromboembolism
Other adverse events of venous thromboembolism treatment

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027361

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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