UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030673 |
|---|---|
| Receipt number | 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 13:23:44 |
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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
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
smaecvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034901
