UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Masayoshi Kiyokuni
Organization	Yokohama city university
Division name	Cardiology
Address	3-9 Fukuura, Kanagawa-ku, Yokohama
TEL	045-787-2800
Email	masakiyo@yokohama-cu.ac.jp

Public contact
Name of contact person	Masayoshi Kiyokuni
Organization	Yokohama City University Graduate School of Medicine
Division name	Cardiorenal science
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024982