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Table 2 List of inclusion and exclusion criteria for randomization

From: Study rationale and design of a study of EMPAgliflozin’s effects in patients with type 2 diabetes mellitus and Coronary ARtery disease: the EMPA-CARD randomized controlled trial

Inclusion criteria 1. Age between 40 and 75 years
2. HbA1c between 6.5 and 9.5%
3. Documented known diabetes mellitus type 2 under continuous fixed-dose anti-diabetic treatment for at least 3 months prior to the randomization
4. Documented known coronary artery disease established by coronary angiography under continuous fixed-dose of anti-ischemic treatment for at least 3 months prior to the randomization
5. BMI less than 40 kg/m2
6. Fixed diet and physical activity
7. eGFR greater than 45 ml/min/1.73m2
8. Informed consent given in written form
9. Resting heart rate between 60 to 100 b/min
Exclusion criteria 1. Pregnancy
2. Heart Failure (NYHA class 3–4)
3. Left ventricular ejection fraction < 40%
4. Use of anti-coagulant or anti-platelet drugs (except aspirin 80 mg/daily) for at least 3 months prior to the blood sampling
5. Consumption of alcohol, continuous anti-inflammatory drugs (except aspirin 80 mg/daily) or anti-oxidant supplement
6. Use of pioglitazone
7. History of allergic reaction to SGLT2-i medications
8. History of SGLT2-i medication usage
9. Gastrointestinal malabsorption disease
10. History of CABG, ACS, TIA, CVA or PCI during past 3 month
11. History or presence of malignancy
12. Severe HTN
 Resting systolic blood pressure ≥ 180 mmHg
and/or
 Resting diastolic blood pressure ≥ 120 mmHg
13. Anemia (Hb < 10 g/dl)
14. Platelet count < 100,000/µl
15. History of infection during 1 one month prior to blood sampling
16. History of heart or lung transplant
17. Major psychiatric disorders
18. History of DKA
19. Elevated liver enzymes > 3 times upper normal limit
20. Use of drugs which prolong QT interval
21. Presence of arrhythmia
22. Electrolyte imbalance
23. Patients with pace maker
  1. HbA1c glycated hemoglobin A1c, BMI body mass index, eGFR estimated glomerular filtration rate, NYHA New York Heart Association, SGLT2-I sodium-glucose co-transporter-2 inhibitor, CABG coronary artery bypass graft, ACS acute coronary syndrome, TIA transient ischemic attack, CVA cerebrovascular accident, PCI percutaneous coronary intervention, HTN hypertension, Hb hemoglobin, DKA diabetic ketoacidosis