UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030851 |
|---|---|
| Receipt number | 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 | 2021/02/06 09:33:55 |
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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
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
asezai.med@gmail.com
Sponsor or person
Institute
Nihon University
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
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
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
https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/atcs/advpub/0/advpub_oa.20-00213/_pdf/-char/en
Number of participants that the trial has enrolled
135
Results
Results: Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups.
Results date posted
| 2021 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC.
Participant flow
In all, 135 patients that experienced POAF after cardiac surgery were treated with a DOAC.
Adverse events
Patients were treated with apixaban (n = 31), edoxaban (n = 87), and rivarox- aban (n = 17). Major bleeding (p = 0.011) and gastrointestinal (GI) bleeding (p = 0.047) were signi cantly more frequent in the rivaroxaban group. Stroke was observed in one rivaroxaban group patient and none in the other two groups.
Outcome measures
We de ned the primary endpoints: major bleeding events that required a blood transfusion such as major postoperative bleeding, GI bleeding, or cerebral hemor- rhage; minor bleeding events that were clinically signi - cant; thromboembolic events; and the last day of the 2-month treatment period. The secondary endpoints were as follows: hemoglobin (Hb), sCr and CRCL were at baseline levels on days 1 and 3, week 1, and month 1; prothrombin time (PT) was at baseline levels on day 1, week 1, and month 1; and activated partial thromboplas- tin time (APTT) was at baseline levels on day 1, week 1, and month 1.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035226
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