UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)
Title of the study (Brief title)	The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)(iDOAC registry)
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine whether DOAC is safe and efficient similar to warfarin in patients with AF.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the new events of stroke and/or systemic embolism by the type of anticoagulant and therapy (medicine vs non medicine) during follow-up period of 12M after informed cocent.
Key secondary outcomes	Death(cardiovascular death/non-cardiovascular death), stroke(ischemic/hemorrhagic/unclassified), systemic embolism, cardiovascular event(acute myocardial infarction/unstable angina), hemorrhagic event (intracranial bleeding except hemorrhagic stroke, gastrointestinal bleeding), adverse event, others

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Japanese patient with anticoagulant therapy for non valvular atrial fibliration (2)Patient with 20 years old and older (3)Patient signed Informed consent
Key exclusion criteria	(1)Patient recieved or will recieve catheter ablation during follow up. (2)Patient recieved catheter ablation for atrial fibliration in the past 6 month. (3)In patient with cancer, not noticed of cancer at the time of informed consent. (4)Patient judged unsuitable for the study by prncipal investigator or subinvetigator
Target sample size	1000

Research contact person
Name of lead principal investigator	Kenzo Hirao
Organization	Tokyo Medical and Dental University
Division name	Heart Rhythm Center
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5231
Email	0160.cvm@tmd.ac.jp

Public contact
Name of contact person	Shingo Maeda
Organization	Tokyo Medical and Dental University
Division name	Heart Rhythm Center
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5231
Homepage URL
Email	smaecvm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	青梅市立総合病院（東京都）、柏市立柏病院（千葉県）、亀田総合病院（千葉県）、災害医療センター（東京都）、さいたま赤十字病院（埼玉県）、新百合ヶ丘総合病院（神奈川県）、草加市立病院（埼玉県）、東京共済病院（東京都）、JA とりで総合医療センター（茨城県）、平塚共済病院（神奈川）、武蔵野赤十字病院（東京都）、横浜みなと赤十字病院（神奈川県）、横浜南共済病院（神奈川県）、山手メディカルセンター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	.

Management information
Registered date	2018 Year 01 Month 04 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034901