UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study
Title of the study (Brief title)	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	Naoki Kanemitsu
Organization	Mitsubishi Kyoto Hospital
Division name	Cardiovascular Surgery
Address	1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan
TEL	075-381-2111
Email	mitsubishikyoto.cvs@gmail.com

Public contact
Name of contact person	Hiroaki Osada
Organization	Mitsubishi Kyoto Hospital
Division name	Cardiovascular Surgery
Address	1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan
TEL	075-381-2111
Homepage URL
Email	osahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of cardiovascular surgery, Mitsubishi Kyoto Hospital
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012762