UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010907
Receipt number R000012762
Scientific Title Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study
Date of disclosure of the study information 2013/06/10
Last modified on 2017/06/16 23:12:02

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Basic information

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

Condition

angina pectoris

Classification by specialty

Cardiology Cardiovascular surgery Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of cardiovascular surgery, Mitsubishi Kyoto Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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 06 Month 10 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name