UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021668 |
|---|---|
| Receipt number | R000024982 |
| Scientific Title | Safety and efficacy of intra-procedural landiolol, a very short acting beta-1 adrenergic receptor blocker, in primary percutaneous coronary intervention for acute myocardial infarction |
| Date of disclosure of the study information | 2016/03/29 |
| Last modified on | 2017/06/05 00:21:22 |
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Basic information
Public title
Safety and efficacy of intra-procedural landiolol, a very short acting beta-1 adrenergic receptor blocker, in primary percutaneous coronary intervention for acute myocardial infarction
Acronym
Safety and efficacy of landiolol in primary percutaneous coronary intervention for acute myocardial infarction
Scientific Title
Safety and efficacy of intra-procedural landiolol, a very short acting beta-1 adrenergic receptor blocker, in primary percutaneous coronary intervention for acute myocardial infarction
Scientific Title:Acronym
Safety and efficacy of landiolol in primary percutaneous coronary intervention for acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether intra-procedural landiolol reduces reperfusion injury assessed by electrocardiogram without increasing adverse events for those patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary efficacy endpoint was reperfusion status after the repercussion therapy, assessed by ST resolution, myocardial blush grade, TIMI flow, and creatine kinase and safety endpoint was adverse cardiac events during admission and within 12 months after the discharge of those patients.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol (3mcrg/kg/min) is started while performing primary percutaneous coronary intervention for acute myocardial infarction. It continues 6-24 hours after the admission.
Interventions/Control_2
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 with acute myocardial infarction who treated by primary percutaneous coronary intervention
Key exclusion criteria
HR<50bpm
Killip>2
History of myocardial infarction
2or3 AV block
B blocker before admission
History of asthma
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kiyokuni |
Organization
Yokohama city university
Division name
Cardiology
Zip code
Address
3-9 Fukuura, Kanagawa-ku, Yokohama
TEL
045-787-2800
masakiyo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kiyokuni |
Organization
Yokohama City University Graduate School of Medicine
Division name
Cardiorenal science
Zip code
Address
3-9 Fukuura, Kanagawa-ku, Yokohama
TEL
045-832-1111
Homepage URL
masakiyo@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine Cardiorenal science
Institute
Department
Personal name
Funding Source
Organization
none
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 | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024982
