UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020069 |
|---|---|
| Receipt number | 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 11:46:04 |
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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
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
n-watanabe@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Medicine,Showa university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023184
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
