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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000037139
Receipt No. R000042325
Scientific Title Muticenter trial on Apixavan or Edoxiavan for postoperative atrial fibrillation (Pilot study)
Date of disclosure of the study information 2019/06/22
Last modified on 2019/08/06

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Basic information
Public title Muticenter trial on Apixavan or Edoxiavan for postoperative atrial fibrillation (Pilot study)
Acronym Muticenter trial on Apixavan or Edoxiavan for postoperative atrial fibrillation (Pilot study)
Scientific Title Muticenter trial on Apixavan or Edoxiavan for postoperative atrial fibrillation (Pilot study)
Scientific Title:Acronym Muticenter trial on Apixavan or Edoxiavan for postoperative atrial fibrillation (Pilot study)
Region
Japan

Condition
Condition partial fibrillation after cardiac surgery
Classification by specialty
Cardiology 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 Apixavan and Edoxiavan for atrial fibrillation after cardiac surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bleeding event
Thromboembolic event
Key secondary outcomes 1) Hb, Ht, BUN, Cr, eGFR, AST, ALT
2) PT-INR, APTT
3) uric blood
4) Blood loss from drain, blood transfusion

Base
Study type Interventional

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

Intervention
No. of arms 2
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
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
100 years-old >
Gender Male and Female
Key inclusion criteria atrial fibrillation after cardiac surgery
Patients from whom informed consent was obtained
Key exclusion criteria Patients from whom informed consent was not obtained
Hemodialysis
Car<15
valve replacement surgery
Doctor's decision not to register to this regimen
Target sample size 200

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 1738610
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 1738610
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 School of Medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nikon University Hospital, Tokyo Rinkai Hospital, Kawaguchi Municipal Medical Center, Sagamihara Kyodo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon University Itabashi Hospital
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 日大板橋病院(東京都)、日本大学病院(東京都)、東京臨海病院(東京都)、川口医療センター(埼玉県)、相模原協同病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 22 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 Terminated
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2019 Year 04 Month 05 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2022 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 22 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042325

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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