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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030851
Receipt No. R000035226
Scientific Title Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
Date of disclosure of the study information 2018/01/17
Last modified on 2020/01/12

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Basic information
Public title Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
Acronym Comparative study of various DOACs for atrial fibrillation after cardiac surgery
Scientific Title Comparative study of various DOACs for atrial fibrillation after cardiac surgery(prospective observation research)
Scientific Title:Acronym Comparative study of various DOACs for atrial fibrillation after cardiac surgery
Region
Japan

Condition
Condition Patients who underwent cardiac surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to elucidate the effectiveness and problems of various DOACs for atrial fibrillation after cardiac surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bleeding event
Ischemic cerebrovascular event
Key secondary outcomes Renal dysfunction, Hemoglobin, pericardial effusion (UCG).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Apixaban group(2.5mgX2/day or 5mgX2/day)
Interventions/Control_2 Edoxaban group (30mgX1/day or 60mgX1/day)
Interventions/Control_3 Riveroxaban group(10mgX1/day or 15mgX1/day)
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 atrial fibrillation after cardiac surgery
Key exclusion criteria valve replacement surgery
Doctor's decision not to register to this regimen
Target sample size 100

Research contact person
Name of lead principal investigator
1st name AKira
Middle name
Last name Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code 173-8610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email asezai.med@gmail.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code 173-8610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email asezai.med@gmail.com

Sponsor
Institute Nihon University
Institute
Department

Funding Source
Organization self funding
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 Nihon University School of Medicine
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
Tel 03-3972-8111
Email asezai.med@gmail.com

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 日本大学医学部付属板橋病院

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 17 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 134
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
2014 Year 04 Month 01 Day
Date of IRB
2014 Year 04 Month 07 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 17 Day
Last modified on
2020 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035226

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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