UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial
Title of the study (Brief title)	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	Atsushi Hirohata
Organization	The Sakakibara Heart Institute of Okayama
Division name	Cardiovascular Medicine
Address	2-5-1, Nakaicho, Kitaku, Okayama
TEL	086-225-7111
Email	hirohata@tg7.so-net.ne.jp

Public contact
Name of contact person	Takaya Kawauchi, Nobuyuki Kagiyama
Organization	The Sakakibara Heart Institute of Okayama
Division name	Cardiovascular Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023885