UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000023184