UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020505 |
|---|---|
| Receipt number | R000023098 |
| Scientific Title | The effect of medical therapy for atrial fibrillation after cardiovascular surgery |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2016/01/08 18:09:43 |
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Basic information
Public title
The effect of medical therapy for atrial fibrillation after cardiovascular surgery
Acronym
The effect of medical therapy for atrial fibrillation after cardiovascular surgery
Scientific Title
The effect of medical therapy for atrial fibrillation after cardiovascular surgery
Scientific Title:Acronym
The effect of medical therapy for atrial fibrillation after cardiovascular surgery
Region
| Japan |
Condition
Condition
atrial fibrillation after cardiovascular surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of landiolol and verapamil for atrial fibrillation after cardiovascular surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
sinus rhythm
Key secondary outcomes
rate control
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
medical therapy of randiolol injection for atrial fibrillation after cardiovascular surgery
Interventions/Control_2
medical therapy of verapamil injection for atrial fibrillation after cardiovascular surgery
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with sinus rhythm who developed atrial fibrillation with rapid ventricular response, heart rate over 100 beats per minite within 3 days after cardiovascular surgery
Key exclusion criteria
cardiogenic shock
heart block
congestive heart failure
pace maker dependent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiko Goda |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
Address
Fukuura3-9, Kanazawaku, Yokohama, Japan
TEL
045-787-2645
go.supra1203@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiko Goda |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
Address
Fukuura3-9, Kanazawaku, Yokohama, Japan
TEL
045-787-2645
Homepage URL
go.supra1203@gmail.com
Sponsor or person
Institute
Department of Surgery, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Yokohama City University
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
| 2016 | Year | 01 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 09 | 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
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2016 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023098
