UMIN-CTR Clinical Trial

Public title

Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study

Acronym

Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting

Scientific Title

Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study

Scientific Title:Acronym

Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting

Region

Japan

Condition

angina pectoris

Classification by specialty

Cardiology	Cardiovascular surgery	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aims of this study are to evaluate whether preoperative bisoprolol fumarate (selective beta-1 antagonist) administration contributes to the prevention of postoperative atrial fibrillation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

new onset of postoperative atrial fibrillation during hospitalization

Key secondary outcomes

all cause of death, cardiovascular death, myocardial infarction, pace maker implantation, cardiac arrest

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

(1)At least a week before surgery, patients will be randomly assigned to B-group or non B-group.
(2)B-group will receive bisoprolol fumarate (Maintate) at least a week before surgery. Dosage of of bisoprolol fumarate depends on heart rate (HR) at first visit (HR>=70bpm: Maintate 2.5mg/day, HR<70bpm: Maintate 1.25mg/day)
(3)Both group will receive Maintate 1.25mg/day from postoperative day1 and dosage will increase up to 2.5mg/day depends on patients' tolerance.

Interventions/Control_2

(1) At least a week before surgery, patients will be randomly assigned to B-group or non B-group. Non B-group will receive no bisoprolol fumarate (Maintate) before surgery.
(2) Both group will receive Maintate 1.25mg/day from postoperative day1 and dosage will increase up to 2.5mg/day depends on patients' tolerance.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects were patients who were scheduled to undergo isolated CABG. Including criteria as follows,
(1) Patients without beta-blocker administration at the registration
(2) Left ventricular ejection fraction > 50%
(3) Age>=20 years
(4) Informed consent was provided by each patient after receiving an explanation about the study.

Key exclusion criteria

(1) Emergency surgery cases
(2) Patients with a history of chronic atrial fibrillation, paroximal atrial fibrillation, 2nd- 3rd degree atrioventricular block, sinus bradycardia
(3) Prior pacemaker implantation
(4) Patients with beta-blocker administration at the registration
(5) Pregnant woman
(6) Patients who were considered not adequate to be included in the study by an attending physician

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Kanemitsu

Organization

Mitsubishi Kyoto Hospital

Division name

Cardiovascular Surgery

Zip code

Address

1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan

TEL

075-381-2111

Email

mitsubishikyoto.cvs@gmail.com

Name of contact person

1st name
Middle name
Last name	Hiroaki Osada

Organization

Mitsubishi Kyoto Hospital

Division name

Cardiovascular Surgery

Zip code

Address

1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan

TEL

075-381-2111

Homepage URL

Email

osahiro@kuhp.kyoto-u.ac.jp

Institute

Department of cardiovascular surgery, Mitsubishi Kyoto Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2013

Year

06

Month

03

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

08

Day

Last modified on

2017

Year

06

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012762