UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023688 |
|---|---|
| Receipt number | R000027281 |
| Scientific Title | Impact of Bisoprolol tape on prevention of atrial fibrillation after coronary artery bypass grafting |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/09/03 17:56:47 |
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Basic information
Public title
Impact of Bisoprolol tape on prevention of atrial fibrillation after coronary artery bypass grafting
Acronym
Bisoprolol tape study
Scientific Title
Impact of Bisoprolol tape on prevention of atrial fibrillation after coronary artery bypass grafting
Scientific Title:Acronym
Bisoprolol tape study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of postoperative incidence of paroxysmal atrial fibrillation by Bisoprolol tape
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative incidence of paroxysmal atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
2 days administration of Bisoprolol tape (4mg) from the day of surgery
Interventions/Control_2
control group
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
Elective isolated CABG
Key exclusion criteria
Bradycardia (HR<50) AV block
Hypotension (BP<90)
HD patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arudo Hiraoka |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Cardiovascular Surgery
Zip code
Address
2-5-1 Nakaicho, Kita-ku, Okayama, 700-0804, Japan
TEL
086-225-7111
bassbord1028@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arudo Hiraoka |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Cardiovascular Surgery
Zip code
Address
2-5-1 Nakaicho, Kita-ku, Okayama, 700-0804, Japan
TEL
086-225-7111
Homepage URL
bassbord1028@yahoo.co.jp
Sponsor or person
Institute
The Sakakibara Heart Institute of Okayama
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027281
