SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study
- Sponsor
- Yonsei University
- Study ID
- NCT07198191
- Status
- Active Not Recruiting
Conditions
- Acute Myocardial Infarction (AMI)
- Type 2 Diabetes Mellitus (T2DM)
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) — DRUGExposure to SGLT2 inhibitors following AMI in patients with T2DM
- DPP4 inhibitors — DRUGExposure to DPP4 inhibitors following AMI in patients with T2DM
Study Details
This observational, retrospective cohort study aims to evaluate the impact of sodium-glucose cotransporter 2 (SGLT2) inhibitor use after acute myocardial infarction (AMI) in patients with type 2 diabetes mellitus (T2DM). Using the nationwide database from the Korean National Health Insurance Service, the investigators will compare cardiovascular outcomes between patients treated with SGLT2 inhibitors and those treated with dipeptidyl peptidase-4 (DPP4) inhibitors after AMI. The study period includes patients diagnosed with AMI between September 2014 and June 2021, with follow-up data available through June 2022. The primary outcomes include major cardiovascular events (death, myocardial infarction, stroke) and bleeding events. This study will provide real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea.
Key Dates
- Start date
- Sep 1, 2014
- Status verified
- Sep 2025
- Primary completion
- Jun 30, 2022
- Completion
- Aug 30, 2026
Study Design
- Enrollment
- 200,000 participants (estimated)
Arms
- Arm: SGLT2 Inhibitor GroupPatients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction.
- Arm: DPP4 Inhibitor GroupPatients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction.
Primary Outcome Measure
Incidence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: From index date (hospitalization for AMI), upto 365 days ]
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