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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000010907 |
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Date of registration:
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10/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study
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Scientific title:
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Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting: randomized, prospective, open-label study - Bisoprolol fumarate; for prevention of atrial fibrillation after coronary artery bypass grafting |
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Date of first enrolment:
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2013/06/10 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012762 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Naoki Kanemitsu |
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Address:
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1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan
Japan |
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Telephone:
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075-381-2111 |
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Email:
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mitsubishikyoto.cvs@gmail.com |
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Affiliation:
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Mitsubishi Kyoto Hospital Cardiovascular Surgery |
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Name:
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Hiroaki Osada |
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Address:
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1 Katsuragoshomachi Nishikyo-ku Kyoto, Japan
Japan |
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Telephone:
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075-381-2111 |
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Email:
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osahiro@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Mitsubishi Kyoto Hospital Cardiovascular Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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angina pectoris
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Intervention(s)
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(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.
(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.
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Primary Outcome(s)
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new onset of postoperative atrial fibrillation during hospitalization
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Secondary Outcome(s)
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all cause of death, cardiovascular death, myocardial infarction, pace maker implantation, cardiac arrest
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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