UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010696 |
|---|---|
| Receipt number | R000012459 |
| Scientific Title | Efficacy of beta blocker for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2020/05/08 22:19:15 |
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Basic information
Public title
Efficacy of beta blocker for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention
Acronym
Efficacy of beta blocker for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention
Scientific Title
Efficacy of beta blocker for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention
Scientific Title:Acronym
Efficacy of beta blocker for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of beta blocker in cardiac function for the patients with acute coronary syndrome undergoing primary percutaneous coronary intervention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac function
incidence of arrhythmias
HR,blood pressure ,cardial index ,PA
Key secondary outcomes
CK,BNP
mortarity complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with landiolol
Interventions/Control_2
conventional treatment without 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
acute coronary syndrome
Key exclusion criteria
systolic blood pressure of less than 80mmHg or heart rate of less than 50 beats/min
2-AV block or 3-AV block
history of side effects of beta blocker
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ajioka Masayoshi |
Organization
Tosei General Hospital
Division name
Department of Cardiology
Zip code
Address
160,NISHIOIWAKE-CHO,SETO,AICHI 489-8642
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakaguchi Teruhiro |
Organization
Tosei General Hospital
Division name
Department of Cardiology
Zip code
Address
160,NISHIOIWAKE-CHO,SETO,AICHI 489-8642
TEL
Homepage URL
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2013 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2013 | 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
| 2013 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012459
