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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017551
Receipt No. 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

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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
Email 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
Email kwatadani@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute of Biomedical and Health Sciences
Applied Life Sciences
Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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