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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | UMIN000024248 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Acute myocardial infarction with Type 2 Diabetes | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |