UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037139 |
|---|---|
| Receipt number | 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 15:32:56 |
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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
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
asezai.med@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042325
| Research Plan | |
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