UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021668
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email masakiyo@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine Cardiorenal science
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024982

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.