UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006348 |
|---|---|
| Receipt number | R000007495 |
| Scientific Title | Comparative effects of amiodarone vs bisoprolol for postoperative atrial fibrillation |
| Date of disclosure of the study information | 2011/09/20 |
| Last modified on | 2015/10/20 22:39:34 |
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Basic information
Public title
Comparative effects of amiodarone vs bisoprolol for postoperative atrial fibrillation
Acronym
Comparative effects of amiodarone vs bisoprolol for postoperative atrial fibrillation
Scientific Title
Comparative effects of amiodarone vs bisoprolol for postoperative atrial fibrillation
Scientific Title:Acronym
Comparative effects of amiodarone vs bisoprolol for postoperative atrial fibrillation
Region
| Japan |
Condition
Condition
valve disease or coronary artery disease with hypertension
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know whether preoperative administration of beta blocker can supress the new onset of postoperative atrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
new onset of postoperative atrial fibrillation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Take amiodaron 400 mg a day for 7 days preoperatively and resume taking amiodaron 200 mg a day on the first postoperative day
Interventions/Control_2
Take bisoprolol 5 mg a day for 7 days preoperatively and resume taking bisoprolol 5 mg a day on the first postoperative day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
those who has hypertension and going to have cardiac operation such as valve replacement, valve plasty or coronary artery bypass grafting
Key exclusion criteria
low cardiac output, congested heart failure, emergency operation, paroxysmal atrial fibrillation or flutter, PSVT, pacemaker or ICD implant, those who takes group 1 or 3 antiarrhythmic medication, hepatic insufficiency, bradycardia less than HR 50/min, more than second degree atrioventricular block, hemodyalysis patients, those who has beta blocker preoperatively
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichihara Yuki |
Organization
Yamanashi prefectural central hospital
Division name
cardiovascular surgery
Zip code
Address
1-1-1, Fujimi, Kouhu-shi, Yamanashi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamanashi prefectural central hospital
Division name
cardiovascular surgery
Zip code
Address
TEL
055-253-7111
Homepage URL
Sponsor or person
Institute
Yamanashi prefectural central hospital
Institute
Department
Personal name
Funding Source
Organization
Yamanashi prefectural central hospital
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
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
| 2011 | Year | 09 | Month | 20 | 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
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 20 | 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
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2015 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007495
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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