UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036637
Receipt No. 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 (Ver. 1)

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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
Last 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
Email mfujii-cvs@umin.ac.jp

Public contact
1st 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
Email mfujii-cvs@umin.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041738