Ischemic heart disease, Type 2 diabetes mellitus
Conditions
Interventions
Additional treatment with empagliflozin in insuffiently controlled type 2 diabetes.
Intensive additional standard treatment without SGLT-2 inhibitor in insuffiently controlled type 2 diabetes.
Sponsors
Department of Cardiology, NTT Medical Center Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with objective evidence of myocardial ischemia who planned to receive percutaneous coronary intervention using drug eluting stent,and with type 2 diabetes with a HbA1c level >7.0% and a fasting plasma glucose level > 126 mg/dl.
Exclusion criteria
Exclusion criteria: Use of SGLT-2 inibitor at baseline Use of insulin Patients with moderate or severe chronic kidney disease (eGFR <45) Patients with ST elevated myocardial infarction, chronic total occlusion, significant left main lesion, in-stent restenosis lesion Endocrine and gastrointestinal disorders Hepatic dysfunction (Child-Pugh score > 10) Patients with malignancy Patients with type 1 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of neointimal tissue 12 months after drug eluting stent between diabetes patients with empagliflozin treatment and standard therapy; evaluated by optical coherence tomography. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of ultrasound cardiography finding 12 months after intervention. The changes of physical examination and laboratory findings including glucose (fasting glucose level, 1.5 AG, HbA1c),lipid parameter and inflamattory cytokine (hsCRP). | — |
Countries
Japan
Contacts
Public ContactTakehiro Hashikata
NTT Medical Center Tokyo Department of Cardiology
Outcome results
None listed