UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036637 |
|---|---|
| Receipt number | R000041738 |
| Scientific Title | Effect of postoperative landiolol administration for atrial fibrillation after off pump coronary artery bypass surgery. |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2019/05/01 23:50:21 |
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Basic information
Public title
Effect of postoperative landiolol for atrial fibrillation
Acronym
Effect of postoperative landiolol for atrial fibrillation
Scientific Title
Effect of postoperative landiolol administration for atrial fibrillation after off pump coronary artery bypass surgery.
Scientific Title:Acronym
Effect of postoperative landiolol for atrial fibrillation after OPCAB
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of postoperative landiolol administration for atrial fibrillation after off pump coronary artery bypass surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of postoperative atrial fibrillation
Key secondary outcomes
effect of postoperative atrial pacing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
postoperative landiolol 5microg/kg/min, under controlled from 60 to 80 bpm until carvedilol intake(atrial pacing -/+) .
Interventions/Control_2
no landiolol
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
patients undergoing off-pump coronary artery bypass surgery
Key exclusion criteria
preoperative atrial fibrillation, sicks sinus syndrome, low EF, asthma, uncontrolled diabetes mellitus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School Chiba-Hokusoh Hospital
Division name
Cardiovascular surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
mfujii-cvs@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School Chiba-Hokusoh Hospital
Division name
Cardiovascular surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
mfujii-cvs@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo, Tokyo
Tel
03-3822-2131
mfujii-cvs@umin.ac.jp
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
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.minervamedica.it/en/journals/cardiovascular-surgery/article.php?cod=R37Y2012N03A0369
Publication of results
Partially published
Result
URL related to results and publications
https://www.minervamedica.it/en/journals/cardiovascular-surgery/article.php?cod=R37Y2012N03A0369
Number of participants that the trial has enrolled
70
Results
Postoperative atrial fibrillation occurred in 4 (11.1%) of the 36 patients in the landiolol group, compared with 11 (32.3%) of the 34 patients in the control group.
Results date posted
| 2019 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2012 | Year | 01 | Month | 17 | Day |
Baseline Characteristics
Control Landiolol p value
Age(y) 70 67 0.07
Male(%) 56 81 0.04
Height(cm) 157 161 0.09
Weight(kg) 58 60 0.45
Pre-beta(%) 68 56 0.33
Hypertension(%) 82 67 0.17
DM(%) 56 69 0.32
LA(mm) 37 38 0.31
LVEF(%) 60 54 0.06
Op time(min) 259 253 0.76
Grafts 3.5 3.2 0.31
W-B(ml) 2150 2311 0.47
p/o Hb(g/dl) 10.0 10.5 0.04
p/o CK-MB(IU/L) 12 15 0.11
p/o CRP(ng/ml) 6.7 8.2 0.50
Participant flow
70cases
Contorol 34cases
Landiolol 36cases
Adverse events
none
Outcome measures
Postoperative atrial fibrillation occurred in 4 (11.1%) of the 36 patients in the landiolol group, compared with 11 (32.3%) of the 34 patients in the control group(p=0.042).
Plan to share IPD
no
IPD sharing Plan description
no
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2004 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2004 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2004 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2008 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041738
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| Registered date | File name |
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