UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Tosei General Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012459