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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020951
Receipt No. 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

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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
Email 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
Email tkawauchi1227@yahoo.co.jp

Sponsor
Institute The Sakakibara Heart Institute of Okayama
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023885

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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