UMIN-CTR Clinical Trial

Basic information
Public title	Impact of Empagliflozin on Infarct Size and Outcomes Following Primary PCI
Acronym	EMPA-AMC study
Scientific Title	Impact of Empagliflozin on Infarct Size and Outcomes Following Primary PCI
Scientific Title:Acronym	EMPA-AMC study
Region	Japan

Condition
Condition	Acute myocardial infarction with Type 2 Diabetes
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate whether Empagliflozin is effective in reducing cardiovascular events and in improving infact size compared with sitagliptin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in infarct size assessed by BMIPP Scintigraphy 6 months after the intervention
Key secondary outcomes	1)Composite cardiovascular event rate after 12 months of treatment 2)Change in daily glucose profile (SD, MAGE) 3)Changes of variables as follows from pre-treatment to 6 months after treatment HbA1c(NGSP) and 75g OGTT (glucose and insulin levels after glucose load) the incidence of arrhythmia assessed by Holter ECG the level of BNP 4)Acute changes of variables as follows 3 days before and after the intervention HbA1c(NGSP) and 75g OGTT (glucose and insulin levels after glucose load) the incidence of arrhythmia assessed by Holter ECG the level of BNP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin group:start with Empagliflozin 10 mg/day and up to 25 mg/day at least 6 months after the intervention
Interventions/Control_2	Sitagliptin group:start with Sitagliptin 50 mg/day and up to 100 mg/day at least 6 months after the intervention
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients coronary acute myocardial infarction with type 2 diabetes
Key exclusion criteria	Patients meeting one of the following conditions will be excluded: 1) poor control:HbA1c(NGSP)>8.5, or under treatment of diabetes, or type 1 diabetes 2)severe liver dysfunction 3)severe renal dysfunction (Cre 2.0 mg/dL) 4)severe heart failure) (NYHA/New York Heart Association stage III or severer) 5)Malignancies or other diseases with poor prognosis 6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant 7) past medical history of hypersensitivity to investigational drugs 8) judged as ineligible by clinical investigators
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaru KURODA
Organization	Akashi Medical Center
Division name	Cardiology
Zip code
Address	743-33, Yagi, Okubo-cho, Akashi city, Hyogo, 6740063, JAPAN
TEL	078-936-1101
Email	kuroro19800115@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Masaru KURODA
Organization	Akashi Medical Center
Division name	Cardiology
Zip code
Address	743-33, Yagi, Okubo-cho, Akashi city, Hyogo, 6740063, JAPAN
TEL	078-936-1101
Homepage URL
Email	kuroro19800115@hotmail.com

Sponsor
Institute	Akashi Medical Center
Institute
Department

Funding Source
Organization	Akashi Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Wakayama Medical University
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 10 Month 01 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
Date of protocol fixation	2016 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 01 Day
Last modified on	2016 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027888

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.