UMIN-CTR Clinical Trial

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	the rates of the following events: stroke; systemic embolism; ischemic stroke; hemorrhagic stroke; intracranial hemorrhage; cardiovascular events (including myocardial infarction, stroke, systemic embolism, and death from bleeding); and bleeding events (including clinically significant bleeding and minor bleeding)

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	564-8565
Address	6-1 Kishibe-shinmachi, Suita
TEL	0661701070
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	564-8565
Address	6-1 Kishibe-shinmachi, Suita
TEL	0661701070
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	6-1 Kishibe-shinmachi, Suita
Tel	0661701070
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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	928
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	Main results already published
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 10 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	2021 Year 10 Month 18 Day

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