UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034198 |
|---|---|
| Receipt number | R000038985 |
| Scientific Title | Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve. (Retrospective observational study) |
| Date of disclosure of the study information | 2018/09/19 |
| Last modified on | 2020/03/23 09:08:29 |
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Basic information
Public title
Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve.
(Retrospective observational study)
Acronym
BPV-AF registry (Retro)
Scientific Title
Registry of antithrombotic therapy in patients with atrial fibrillation under replacement with bioprosthetic valve.
(Retrospective observational study)
Scientific Title:Acronym
BPV-AF registry (Retro)
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 and outcome of antithrombotic therapy 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 collect the data satisfied both 1) and 2) over 6 months.
Key exclusion criteria
1) Patients who were participating in an interventional study during the period for investigation
2) Patients who have a mechanical valve in their body
Target sample size
200
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 Kishibeshinmachi, Suita, Osaka 564-8565 Japan
TEL
06-6170-1070
izumi-ch@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Kondo |
Organization
DAIICHI SANKYO RD NOVARE CO., LTD.
Division name
Clinical Development Department
Zip code
140-8710
Address
1-2-58 Hiromachi, Shinagawa-ku, Tokyo 140-8710 Japan
TEL
03-5436-8544
Homepage URL
kondo.masanori.v8@rdn.daiichisankyo.co.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 Kishibeshinmachi, Suita, Osaka 564-8565 Japan
Tel
06-6170-1070
rec-office-ac@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
国立循環器病研究センター（大阪府）
神戸市立医療センター中央市民病院（兵庫県）
天理よろづ相談所病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.jjcc.2020.02.006
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jjcc.2020.02.006
Number of participants that the trial has enrolled
214
Results
The mean observation period was 46.0 months. Warfarin was administered to 176 patients (82.2%), direct oral anticoagulants to 16 patients (7.5%), and antiplatelet drugs to 13 patients (6.1%). The number of patients who were treated with DOAC was increasing in the later period of registration. Stroke/systemic embolism was observed in 14 patients (1.77 patients/100 person-years [PY]). Major bleeding was observed in 22 patients (2.83/100 PY).
Results date posted
| 2020 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients with AF and bioprosthetic valves between March 1, 2011, and March 31, 2018.
Participant flow
Consecutive patients with AF and bioprosthetic valves were enrolled from 3 participant hospitals.
Adverse events
None
Outcome measures
The primary efficacy endpoint was the incidence of stroke or systemic embolism during the observation period. The primary safety endpoint was the incidence of major bleeding events during the observation period, based on International Society of Thrombosis and Hemostasis (ISTH) criteria
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Multicenter Retrospective Observational Study
Management information
Registered date
| 2018 | Year | 09 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038985
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