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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name