UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023747
Receipt number 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 2024/02/29 11:57:34

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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 Obstetrics 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 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

TEL

0594-33-1616

Email

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

TEL

0594-22-1211

Homepage URL


Email

n-yamada@kuwanacmc.or.jp


Sponsor or person

Institute

Department of Cardiology and Nephrology, 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

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)、 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

2024 Year 02 Month 29 Day



Link to view the page

Value
https://center6.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