UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020951 |
|---|---|
| Receipt number | R000023885 |
| Scientific Title | Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2016/08/18 15:35:27 |
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Basic information
Public title
Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial
Acronym
Empagliflozin on Acute Coronary Syndrome
Scientific Title
Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial
Scientific Title:Acronym
Empagliflozin on Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome with Type 2 Diabetes
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether Empagliflozin is effective in reducing cardiovascular events and in improving left ventricular function compared with echocardiography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite cardiovascular event rate and change of cardiac function assessed by echocardiography after 12 months of treatment
Key secondary outcomes
1) Target Lesion Revascularization during 12 months
2) Lipid metabolism marker after 6 months
3) Urine and body weight after 48 hours
4) Adverse events until 12 months
5) Change of neuro humoral factor
6) Change of blood pressure, blood sugar and pulse rate
7) Evaluation of quantity and quality of coronary plaque by IVUS after 6 months
8) Exercise tolerance after 6 months
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/6months
Interventions/Control_2
Standard therapy/6months
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 coronary acute syndrome with type 2 diabetes (Hb1Ac>=6.0%)
Key exclusion criteria
1) Patients with hypersensitivity to the components of Empagliflozin
2) Patients with severe ketosis, diabetic coma or pre-coma
3) Patients with severe infection, before and after surgery, severe trauma
4) Patients with dehydration
5) Patients with uncontrolled hypertension (sBP>180mmHg under medication) or low blood pressure (sBP<85mmHg)
6) Patients with advanced renal dysfunction or patients on dialysis (eGFR<30)
7) Patients with severe hepatic dysfunction
8) Patients with congenital heart disease or valvular disease
9) Patients with severe complications such as malignant neoplasm and severe infections
10) Patients with a history of heart transplant
11) Patients with drug or alcohol dependence
12) Patients with urinary tract or genital infection
13) Patients with pregnancy, or possibility and hope
14) Patients who have participated in clinical studies using other investigational or unapproved medicines within 3 months
15) Patients whom physician in charge considered inappropriate for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hirohata |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Nakaicho, Kitaku, Okayama
TEL
086-225-7111
hirohata@tg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Kawauchi, Nobuyuki Kagiyama |
Organization
The Sakakibara Heart Institute of Okayama
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Nakaicho, Kitaku, Okayama
TEL
086-225-7111
Homepage URL
tkawauchi1227@yahoo.co.jp
Sponsor or person
Institute
The Sakakibara Heart Institute of Okayama
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 | 02 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 22 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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