UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017551 |
|---|---|
| Receipt number | R000010502 |
| Scientific Title | Comparative study between non-blinded, randomized, parallel group regarding the preventive effect of the coarse-hydrochloride landiolol for atrial fibrillation after major thoracic vascular surgery |
| Date of disclosure of the study information | 2015/05/13 |
| Last modified on | 2015/07/15 21:06:30 |
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Basic information
Public title
Comparative study between non-blinded, randomized, parallel group regarding the preventive effect of the coarse-hydrochloride landiolol for atrial fibrillation after major thoracic vascular surgery
Acronym
Comparative study between non-blinded, randomized, parallel group regarding the preventive effect of the coarse-hydrochloride landiolol for atrial fibrillation after major thoracic vascular surgery
Scientific Title
Comparative study between non-blinded, randomized, parallel group regarding the preventive effect of the coarse-hydrochloride landiolol for atrial fibrillation after major thoracic vascular surgery
Scientific Title:Acronym
Comparative study between non-blinded, randomized, parallel group regarding the preventive effect of the coarse-hydrochloride landiolol for atrial fibrillation after major thoracic vascular surgery
Region
| Japan |
Condition
Condition
thoracic aortic aneurysm, thoracic aortic dissection
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Parallel group unblinded randomized to evaluate the preventive effect coarse-postoperative atrial fibrillation in patients using a hydrochloride landiolol with Efficacy against tachyarrhythmia perioperative, who underwent thoracic vascular surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients with atrial fibrillation coarse-until 7 days after surgery occurred.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Group treated with the hydrochloride salt landiolol
Interventions/Control_2
Group treated without the hydrochloride salt 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
(a) Age at the time of obtaining informed consent of patients aged 20 years or older
(b) Patients scheduled for thoracic aortic aneurysm or dissection underwent replacement surgery.
(c)Patient consent is obtained in writing with respect to participation in the study
Key exclusion criteria
Corresponding to patient contraindications hydrochloride landiolol
Patients with acute myocardial infarction within 3 days.
Patients with supraventricular arrhythmia that might need treatment.
Patients with severe heart failure (NYHA III degrees or more just before surgery, EF less than 35%).
Patients with atrial fibrillation cause of electrolyte abnormalities, WPW syndrome and hyperthyroidism.
Diastolic blood pressure / systolic patients less than 90/60 mmHg.
Patients with severe asthma.
Patients who take an oral antiarrhythmic drugs or beta blocker.
Patients who were found to be inappropriate physician to carry out the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taijiro Sueda |
Organization
Hiroshima University
Division name
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address
minami ku kasumi 1-2-3, hiroshima city, Hiroshima
TEL
0822575215
sueda@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Watadani |
Organization
Hiroshima University
Division name
Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address
minami ku kasumi 1-2-3, hiroshima city, Hiroshima
TEL
0822575218
Homepage URL
kwatadani@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute of Biomedical and Health Sciences
Applied Life Sciences
Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 05 | Month | 13 | 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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 13 | Day |
Last modified on
| 2015 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010502
