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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010907
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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