UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034198
Receipt No. 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 2019/09/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kondo.masanori.v8@rdn.daiichisankyo.co.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 Kishibeshinmachi, Suita, Osaka 564-8565 Japan
Tel 06-6170-1070
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 214
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 No longer recruiting
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
2019 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.