UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034485 |
|---|---|
| Receipt number | 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 | 2021/10/18 07:25:25 |
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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
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
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
izumi-ch@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
DAIICHI SANKYO CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
