ST-segment elevation myocardial infarction
Conditions
Interventions
Experimental group:Ganagliflozin Proline Tablets
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old, no gender restriction; 2. Meets the diagnostic criteria for type 2 diabetes (refer to "Guidelines for the Prevention and Treatment of Diabetes in China (2024 Edition)", Appendix 15.3), and at screening, HbA1c is >6.5% to = 24 kg/m^2; 4. First occurrence of acute ST-segment elevation myocardial infarction (ischemic chest pain lasting more than 20 minutes, with ST-segment elevation in >=2 contiguous leads [ST-segment elevation criteria: >=0.2 mV in leads V2–V3, >=0.1 mV in other leads]), time from onset to medical visit =2, suitable for dual antiplatelet therapy (DAPT) with aspirin and P2Y12 receptor antagonists (such as ticagrelor, clopidogrel, etc.), and agrees not to change the DAPT regimen during the study; 6. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Individuals with type 1 diabetes or other specific types of diabetes; 2. Those who have had more than two episodes of diabetic ketoacidosis or hyperosmolar hyperglycemic state requiring hospitalization within 6 months prior to screening; 3. Those who have experienced a level 3 hypoglycemic event (requiring assistance from others with treatment and accompanied by consciousness and/or physical changes, without a specific blood glucose threshold) or frequent hypoglycemia (more than 3 occurrences of blood glucose =160 mmHg and/or diastolic blood pressure >=100 mmHg) or clinically significant hypotension (systolic blood pressure 3 times the upper limit of normal, or total bilirubin (TBIL) >2 times the upper limit of normal within 3 months prior to onset; 10. Individuals with systemic reactions such as urinary or reproductive system infections with fever at screening, or those with recurrent (>3 times) urinary or reproductive system infections within 12 weeks prior to screening; 11. Individuals with severe kidney stones (causing serious complications such as urinary obstruction, renal failure, uremia, etc.) or a history of severe recurrent kidney stones; 12. Individuals with malignant tumors, severe liver or kidney failure, respiratory failure, or other conditions deemed by researchers to be progressive in the short term or with a life expectancy of less than 1 year; 13. Individuals with a history of positive human immunodeficiency virus (HIV) antibody. Concomitant Treatment 14. Those who have used SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks prior to screening; 15. Those known to be allergic to Proline Glegliflozin, aspirin, or P2Y12 receptor antagonists; previous clinical research experience 16. Those who have participated in other drug clinical trials within 3 months prior to screening (if it was a placebo-controlled study, participants who were in the placebo group after unblinding can be included); Other Exclusion Criteria 17. Women of childbearing potential who are unwilling to use medically reliable contraceptive methods as judged by the investigator from signing the informed consent to the end of the study (Appendix 15.1), or women who test positive for pregnancy at screening or enrollment, or lactating women; 18. Those who, in the judgment of the investigator, have other serious physiological or psychological conditions (such as depression) that may affect compliance, efficacy, and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, unplanned revascularization, and hospitalization for unstable angina or heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events, including the incidence of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death;Changes from baseline in body weight, waist circumference, hip circumference, BMI, waist-to-hip ratio, waist-to-height ratio, HbA1c, fasting blood glucose, UACR, eGFR, NT-proBNP, blood lipids, liver a;Changes in echocardiographic parameters (left ventricular ejection fraction, left ventricular end-diastolic diameter, left ventricular mass index, end-systolic volume index, etc.); | — |
Countries
China
Contacts
Public ContactYanming Chen
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed