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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034485
Receipt No. R000039323
Scientific Title Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve. (Prospective observational study)
Date of disclosure of the study information 2018/10/15
Last modified on 2019/04/15

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Basic information
Public title Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve.
(Prospective observational study)
Acronym BPV-AF registry
Scientific Title Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve.
(Prospective observational study)
Scientific Title:Acronym BPV-AF registry
Region
Japan

Condition
Condition Patients with atrial fibrillation after replacement with bioprosthetic valve.
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the current status of antithrombotic therapy, occurrence and relationship of the events in patients with atrial fibrillation after replacement with bioprosthetic valve.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of stroke/systemic embolism and major bleeding during the observation period
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who 3 months have passed after replacement with bioprosthetic valve (Aortic or Mitral valve replacement, surgical operation or TAVI)
2) Patients who have been given the definitive diagnosis of atrial fibrillation
3) Patients who can follow-up the data over 1 year during the observation period
4) Patients who are able to provide written informed consent
Key exclusion criteria 1) Patients currently participating or scheduled to participate in intervention studies
2) Patients who are judged by research director as valvular atrial fibrillation
3) Any patients who are deemed inappropriate by research director or co-investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Chisato
Middle name
Last name Izumi
Organization National Cerebral and Cardiovascular Center
Division name Department of Cardiovascular Medicine
Zip code 565-8565
Address 5-7-1 Fujishirodai, Suita
TEL 0668335012
Email izumi-ch@ncvc.go.jp

Public contact
Name of contact person
1st name Chisato
Middle name
Last name Izumi
Organization National Cerebral and Cardiovacular Center
Division name Department of Cardiovascular Medicine
Zip code 565-8565
Address 5-7-1 Fujishirodai, Suita
TEL 0668335012
Homepage URL
Email izumi-ch@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
DAIICHI SANKYO CO., LTD.
Institute
Department

Funding Source
Organization DAIICHI SANKYO CO., LTD
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 National Cerebral and Cardiovacular Center
Address 5-7-1 Fujishirodai, Suita
Tel 0668335012
Email izumi-ch@ncvc.go.jp

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 15施設
聖マリアンナ医科大学病院(神奈川県)
地方独立行政法人 静岡市立静岡病院(静岡県)
京都大学医学部附属病院(京都府)
国立研究開発法人 国立循環器病研究センター(大阪府)
大阪大学医学部附属病院(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
兵庫県立 姫路循環器病センター(兵庫県)
神戸大学医学部附属病院(兵庫県)
公益財団法人 天理よろづ相談所病院(奈良県)
社会医療法人社団十全会 心臓病センター榊原病院(岡山県)
一般財団法人 平成紫川会 小倉記念病院(福岡県)
長崎大学病院(長崎県)
社会福祉法人恩賜財団 済生会熊本病院(熊本県)
熊本大学医学部附属病院(熊本県)
公益社団法人 宮崎市郡医師会 宮崎市郡医師会病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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
2018 Year 08 Month 23 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multicenter Prospective Observational Study

Management information
Registered date
2018 Year 10 Month 14 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039323

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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