ischemic heart disease diabets
Conditions
Interventions
Patients are divided into two groups
Intervention group or control group. Treatment period is 12 months. Intervention group: T2DM patients with treatment with dapagliflozin 5mg/day in addition to conventional therapy or those with only
7.5% and there were no safety concerns, dapagliflozin would be up-titrated to 10 mg/day. If HbA1c remains above 7.5% during follow period at week 24 and/or at week 36 from week 24 to week 48, only one
7.5% and there were no safety concerns, doses of the basal OAD will be gradually increased up to the approved maximum doses and then, if HbA1c remains above 7.5% during follow period at week 24 and/or
Sponsors
Division of Cardiology, Nagoya Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. T2DM patients who need PCI due to ischemic heart disease. 2. Patients with baseline HbA1c levels >=6.5% and <9%. 3. Patients are currently treated with one or multiple OADs other than pioglitazone or drug naive patients. 4. Patients who have already received treatment with statin. 5. Patients receiving written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with severe ketosis, diabetic coma or precoma 2)Patients with severe infection, perioperative, a severe trauma 3)Patients with moderate renal dysfunction (eGFR: less than 45 ml/min/1.73m2) 4)Patients with severe hepatic dysfunction 5)Patients who are treated with insulin 6)Patients who need treatment with pioglitazone 7)Patients who need treatment with GLP-1RA 8)Patients with a history of hypersensitivity to SGLT-2 inhibitors 9)Women who are or may be pregnant 10)Patients who are treated with PCSK-9 inhibitor 11)Patients who have been determined to be unsuitable for the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Region of interest will be measured by volumetric IVUS at both baseline and 1-year follow-up period. (i) Conventional IVUS: Changes of the percent plaque volume assessed by IVUS. (ii) IB IVUS analysis: Changes of the percent of coronary lipid and fibrous volume assessed by IB-IVUS. The final IVUS exam of PCI is used for IVUS analysis. The target segment is determined in a non-PCI site (> 5 mm proximal or distal to the PCI site), with < 50 % stenosis of the lumen diameter on coronary angiography, in addition to the percentage of plaque area > 20 % at the lumen cross-sectional area. The target segments are assessed at an axial interval of 1 mm for each plaque. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ultrasound of cardiography 2. Major adverse cardio-cerebrovascular events 3. Carotid intima-medial thickness 4. BNP 5. HbA1c and FPG 6. Lipid profile 7. General urinary test | — |
Countries
Japan
Contacts
Public ContactHideki Ishii
Nagoya Graduate School of Medicine Cardiology
Outcome results
None listed