Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial

Efficacy of Empagliflozin on Acute Coronary Syndrome with Type 2 Diabetes: Open-label Randomized Controlled Trial - Empagliflozin on Acute Coronary Syndrome

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020951

Enrollment

100

Registered

2016-02-10

Start date

2016-01-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome with Type 2 Diabetes

Interventions

Empagliflozin/6months Standard therapy/6months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients coronary acute syndrome with type 2 diabetes (Hb1Ac>=6.0%)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Composite cardiovascular event rate and change of cardiac function assessed by echocardiography after 12 months of treatment	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTakaya Kawauchi, Nobuyuki Kagiyama

The Sakakibara Heart Institute of Okayama Cardiovascular Medicine

tkawauchi1227@yahoo.co.jp086-225-7111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026