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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020069
Receipt No. R000023184
Scientific Title Comparison of Efficacy and Safety between Warfarin, Rivaroxaban and Edoxaban in patients with acute pulmonary embolism in showa university
Date of disclosure of the study information 2015/12/10
Last modified on 2020/06/08

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Basic information
Public title Comparison of Efficacy and Safety between Warfarin, Rivaroxaban and Edoxaban
in patients with acute pulmonary embolism in showa university
Acronym Edo-warivashi study in showa university
Scientific Title Comparison of Efficacy and Safety between Warfarin, Rivaroxaban and Edoxaban
in patients with acute pulmonary embolism in showa university
Scientific Title:Acronym Edo-warivashi study in showa university
Region
Japan

Condition
Condition Acute pulmonary embolism
Classification by specialty
Medicine in general Cardiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study are to compare efficacy and safety between Warfarin, Rivaroxaban and Edoxaban in patients with acute pulmonary embolism included severe conditions in showa university
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Score of Central Disease Score and
Thrombus volume in pulmonary vein measured by CT (if possible)
Key secondary outcomes 1)CT index score
2)Coagulation test
3)Change in UCG
4)Length of hospital stay and CCU
5)Length of disappearance of pulmonary embolism from an initial day

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Warfarin administration for 6 months with PTINR betweeen 2.00 and 3.00
Interventions/Control_2 Rivaroxaban administration at the dose of 15mg twice a day in the first 3 weeks.
Subsequently,Rivaroxaban administration at the dose of 15mg once a day for 6 months

Interventions/Control_3 Edoxaban administration at the dose of 60mg(30mg if the patients have the reduced criteria of Edoxaban) once a day for 6 months
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with acute pulmonary embolism who are and hospitalized in Showa University Hospital, Showa University Fujigaoka Hospital and Showa University Koto Toyosu Hospital and needed intensive care
Key exclusion criteria CrCL less than 30ml/min
Patients with acute bleeding
Patients with active malignancy
Patients needed PCPS,IABP and aortic sheathes
Contraindication of each drug
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikazu Watanabe
Organization Department of Medicine,Showa university
Division name Division of Cardiology
Zip code
Address Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL 0337848000
Email n-watanabe@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norikazu Watanabe Toigyu Matsui
Organization Department of Medicine Showa university
Division name Division of Cardiology
Zip code
Address Division of Cardiology 1 tyoume 5 no 8 Hatanodai Shinagawaku Tokyo
TEL 0337848000
Homepage URL
Email n-watanabe@med.showa-u.ac.jp

Sponsor
Institute Division of Cardiology, Department of Medicine,Showa university
Institute
Department

Funding Source
Organization Division of Cardiology, Department of Medicine,Showa university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 昭和大学病院(東京都)・昭和大学藤が丘病院(神奈川県)・昭和大学江東豊洲病院(東京都)
 Showa University Hospital・Showa University Fujigaoka Hospital・Showa University Koto Toyosu Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 10 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 Preinitiation
Date of protocol fixation
2015 Year 11 Month 27 Day
Date of IRB
2015 Year 11 Month 28 Day
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
2018 Year 12 Month 10 Day
Date of closure to data entry
2019 Year 12 Month 10 Day
Date trial data considered complete
2019 Year 12 Month 10 Day
Date analysis concluded
2019 Year 12 Month 10 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 04 Day
Last modified on
2020 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023184

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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