Periprocedural myocardial injury or infarction and acute kidney injury in patients with coronary artery disease with or without chronic kidney disease undergoing coronary angiography with possible percutaneous coronary intervention Coronary artery disease, chronic kidney disease, coronary angiography, percutaneoua coronary intervention, periprocedural myocardial injury, periprocedural myocardial infarction, acute kidney injury.
Conditions
Interventions
Dapagliflozin 10 mg given orally 24 hours and immediate before procedure.,Placebo given orally 24 hours and immediate before procedure.
Experimental Drug,Placebo Comparator Drug
Sponsors
National Science, Research and Innovation Fund (NSRF)
Prince of Songkla University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adult (age 18-75 years old) undergoing elective CAG with possible PCI or elective staged PCI 2. Diagnosed with chronic coronary syndrome or stable acute coronary syndrome (including unstable angina, non-ST segment elevation myocardial infarction, defined as normal or stable elevated or falling high sensitivity troponin before procedure) 3. Estimated glomerular filtration rate more than 30 mL/min/1.73m2 (CKD-EPI formula)
Exclusion criteria
Exclusion criteria: 1. Decline for study participation or not provide informed consent 2. Blood sugar at screening morethan 300 mg/dL 3. Rise in serum creatinine of more than 50 percentage from the baseline value or presumed to have occurred within 7 days. 4. History of allergy to any SGLT2 inhibitor 5. Past or current treatment with any SGLT2 inhibitor 6. History of type 1 diabetes mellitus 7. Current use of insulin 8. Previous history of diabetic ketoacidosis 9. Current treatment with loop diuretic 10. History of any genital infection 11. History of urinary tract infection within 3 months 12. Currently receiving long term (>30 consecutive days) treatment with an oral steroid, immunosuppressive drug 13. Pregnant woman or during lactation period 14. Patients whom their comorbidities, judged by study researcher, may limit the study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary cardiac outcome: Composite of PCI-related MI (type 4a or 4b, see the definitions below) or major myocardial injury within 48 hours after PCI within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Primary kidney outcome: Acute kidney injury defined by 10% increase of serum cystatin C after CAG or PCI compared with baseline value within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software | — |
Secondary
| Measure | Time frame |
|---|---|
| PC-related MI (MI type 4a) within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,MI type 4b within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Major myocardial injury within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Minor myocardial injury within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Any procedural myocardial injury within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Prognostically relevant myocardial injury or infarction according to the consensus document of the ESC working group on cellular biology of the heart and EAPCI within 48 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Absolute change in hs-troponin-T (calculated as 24-hour post-PCI minus pre-PCI measurements) within 24 hours after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Cardiovascular death within 30 days within 30 days after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Myocardial infarction from 48 hours after PCI to 30 days within 30 days after end of intervention Data were recorded in case record forms in the computer that particularly designed for this study and R software,Any stroke: ischemic, hemorrhagic, TIA or unspecified stroke within 30 days after end of intervention Data were recorded in case record forms | — |
Countries
Thailand
Contacts
Public ContactPly Chichareon
Cardiology unit, division of internal medicine, Prince of Songkla
Outcome results
None listed