UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024248 |
|---|---|
| Receipt number | R000027888 |
| Scientific Title | Impact of Empagliflozin on Infarct Size and Outcomes Following Primary PCI |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/10/01 11:20:07 |
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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
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
kuroro19800115@hotmail.com
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027888
