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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030673
Receipt No. R000034901
Scientific Title The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)
Date of disclosure of the study information 2018/01/04
Last modified on 2018/01/04

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Basic information
Public title The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)
Acronym The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)(iDOAC registry)
Scientific Title The safety and efficacy of direct oral anticoagulants in patients with atrial fibrillation (AF)
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenzo Hirao
Organization Tokyo Medical and Dental University
Division name Heart Rhythm Center
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5231
Email 0160.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Maeda
Organization Tokyo Medical and Dental University
Division name Heart Rhythm Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 10 Day
Date of IRB
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

Other
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

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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