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Clinical Trial NCT07198191 (SGLT2i-AMI) for Acute Myocardial Infarction (AMI), Type 2 Diabetes Mellitus (T2DM) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Yonsei UniversitySGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study (SGLT2i-AMI) 200,000 Real-World Evidence Observational
Clinical Trial NCT07198191 (SGLT2i-AMI) is an observational study for Acute Myocardial Infarction (AMI), Type 2 Diabetes Mellitus (T2DM) that is active, not recruiting. It started on September 1, 2014 with plans to enroll 200,000 participants. Led by Yonsei University, it is expected to complete by August 30, 2026. The latest data from ClinicalTrials.gov was last updated on September 30, 2025.
Brief Summary
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 treate...Show More
Detailed Description
Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated substantial cardiovascular benefits in patients with heart failure and chronic kidney disease, independent of glucose-lowering effects. However, their role in patients with acute myocardial infarction (AMI), particularly in the early post-infarction period, has been less clear. Recently, the DAPA-MI and EMPACT-MI randomized controlled trials have pro...Show More
Official Title
Impact of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Population Cohort Study
Conditions
Acute Myocardial Infarction (AMI)Type 2 Diabetes Mellitus (T2DM)Other Study IDs
- SGLT2i-AMI
- IRB No. 9-2023-0049
NCT ID Number
Start Date (Actual)
2014-09-01
Last Update Posted
2025-09-30
Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
200,000
Study Type
Observational
Status
Active, not recruiting
Keywords
SGLT2 inhibitor
Dapagliflozin
Empagliflozin
DPP4 inhibitor
Cardiovascular Outcomes
Heart Failure
Real-world Evidence
NHIS
South Korea
Dapagliflozin
Empagliflozin
DPP4 inhibitor
Cardiovascular Outcomes
Heart Failure
Real-world Evidence
NHIS
South Korea
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
SGLT2 Inhibitor Group Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction. | SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) Exposure to SGLT2 inhibitors following AMI in patients with T2DM |
DPP4 Inhibitor Group Patients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction. | DPP4 inhibitors Exposure to DPP4 inhibitors following AMI in patients with T2DM |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE) | MACE defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke. | From index date (hospitalization for AMI), upto 365 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of Cardiovascular Death | Death from cardiovascular causes, including sudden cardiac death, myocardial infarction, heart failure, or stroke. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of All-cause Death | Death from any cause during follow-up. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Non-fatal Myocardial Infarction | Hospitalization with a primary diagnosis of myocardial infarction (ICD-10 I21-I22), excluding fatal events. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Non-fatal Ischemic Stroke | Hospitalization with a primary diagnosis of ischemic stroke, excluding fatal events. | From index hospitalization for acute myocardial infarction, upto 365 days |
Incidence of Hospital Admission for Heart Failure | Hospitalization with a primary diagnosis of heart failure | From index hospitalization for acute myocardial infarction, upto 365 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
19 Years
Eligible Sexes
All
- Adults aged ≥19 years
- Hospitalization with a primary diagnosis of acute myocardial infarction between September 2014 and June 2021
- Diagnosis of type 2 diabetes mellitus (T2DM)
- Prescription of either an SGLT2 inhibitor or a DPP4 inhibitor after index AMI
- Diagnosis of type 1 diabetes mellitus
- Gestational diabetes mellitus
- End-stage renal disease (ESRD) or history of kidney transplantation
- No use of either SGLT2 inhibitor or DPP4 inhibitor after index AMI
- Short-term use of SGLT2 inhibitor or DPP4 inhibitor (less than 30 days)
- Concomitant use of SGLT2 inhibitor and DPP4 inhibitor
- Incomplete or missing data for key study variables
Yonsei University200 active studies to explore- Chong Kun Dang Pharmaceutical Corp.
- Health Insurance Review & Assessment Service
Study Responsible Party
Yongcheol Kim, Principal Investigator, Principal Investigator, Yonsei University
No contact data.
1 Study Locations in 1 Countries
Gyeonggi-do
Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi-do, 16995, South Korea