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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010512
Receipt No. R000012295
Scientific Title The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Date of disclosure of the study information 2013/04/16
Last modified on 2013/04/16

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Basic information
Public title The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Acronym The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Scientific Title The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Scientific Title:Acronym The bisoprolol medication method for prevention ofatrial fibrillation coronary after cardiac surgery
Region
Japan

Condition
Condition valvular disease, angina
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The bisoprolol effective medication method for prevention of atrial fibrillation coronary after cardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes atrial fibrillation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 preoperation
Interventions/Control_2 preoperation and postoperation
Interventions/Control_3 postoperation
Interventions/Control_4 control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria patient who undergo valve replacement and coronary artery bypass
Key exclusion criteria 1 heart failure, acidosis,
peripheral circulatory failure,
pheochromocytoma
2 LVEF<30%
3 HR<55
4 AMI(within 2 week)
5 atrial fibrillation
6 be-ta blocker(except bisoprolol) medication
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name takano tamaki
Organization shinshu University school of medicine
Division name cardiovascular surgery
Zip code
Address 3-1-1 Asahi, Matumoto-shi, Nagano-ken, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization shinshu University school of medicine
Division name cardiovascular surgery
Zip code
Address
TEL 0263372657
Homepage URL
Email

Sponsor
Institute department of cardiovascular surgery,
shinshu University school of medicine
Institute
Department

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
Email

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
2013 Year 04 Month 16 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 Preinitiation
Date of protocol fixation
2013 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 16 Day
Last modified on
2013 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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