UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035226