Acute Myocardial Infarction (AMI)SGLT2i-AMINCT07198191
SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study
An observational study of Acute Myocardial Infarction (AMI) and Type 2 Diabetes Mellitus (T2DM), run by Yonsei University at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) and DPP4 inhibitors
- How many people
- 200,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2014to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥19 years) with type 2 diabetes mellitus who were hospitalized for acute myocardial infarction in South Korea between September 2014 and June 2021. Eligible patients were identified from the Korean National Health Insurance Service database, with follow-up available through June 2022.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yongin Severance Hospital, Yonsei University Health System
Yongin, Gyeonggi-do, 16995
About this study
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
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.
Read the 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 provided important insights. In DAPA-MI, approximately 1 year of dapagliflozin therapy in patients with recent AMI improved cardiometabolic outcomes but did not reduce the composite endpoint of cardiovascular death or hospitalization for heart failure compared with placebo. Similarly, in EMPACT-MI, treatment with empagliflozin among high-risk patients following AMI did not significantly lower the risk of first hospitalization for heart failure or all-cause death compared with placebo. These findings highlight the need for complementary large-scale real-world data to further clarify the clinical utility of SGLT2 inhibitors in this population.
This investigator-initiated observational cohort study utilizes de-identified claims data from the Korean National Health Insurance Service (NHIS) to evaluate clinical outcomes associated with SGLT2 inhibitor use in patients with type 2 diabetes mellitus (T2DM) after AMI. The study population includes adult patients (≥19 years) hospitalized with AMI (ICD-10 codes I21-I23) between September 2014 and June 2021. Patients are stratified based on use of SGLT2 inhibitors versus dipeptidyl peptidase-4 (DPP4) inhibitors following the index event. Exclusion criteria include prior SGLT2 inhibitor use within 12 months before AMI, malignancy, cardiogenic shock, or missing ICD-10 data.
Outcomes of interest include major adverse cardiovascular events (all-cause mortality, cardiovascular death, recurrent MI, ischemic stroke) and bleeding events (major bleeding, site-specific bleeding, transfusion). Propensity-score matching is performed to adjust for baseline demographic and clinical characteristics. Kaplan-Meier survival curves and Cox proportional hazards models are used to estimate hazard ratios for outcomes.
The primary endpoint is the incidence of major adverse cardiovascular events (MACE). Secondary endpoints include individual cardiovascular events, hospitalization for heart failure, and bleeding events. Subgroup analyses assess outcomes according to comorbid chronic heart failure, chronic kidney disease, and concomitant thiazolidinedione therapy.
This study provides real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea, thereby complementing randomized trial data and informing guideline recommendations for this high-risk population.
- Being tested
- SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin), DPP4 inhibitors
- Keywords
- SGLT2 inhibitor, Dapagliflozin, Empagliflozin, DPP4 inhibitor, Cardiovascular Outcomes, Heart Failure, Real-world Evidence, NHIS, South Korea
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)Drug
Exposure to SGLT2 inhibitors following AMI in patients with T2DM
DPP4 inhibitorsDrug
Exposure to DPP4 inhibitors following AMI in patients with T2DM
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 Inhibitor Group | Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction. Receives: Drug: SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) | |
| DPP4 Inhibitor Group | Patients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction. Receives: Drug: DPP4 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke.
Measured: From index date (hospitalization for AMI), upto 365 days
Secondary outcomes (5)
Incidence of Cardiovascular Death
Death from cardiovascular causes, including sudden cardiac death, myocardial infarction, heart failure, or stroke.
Measured: From index hospitalization for acute myocardial infarction, upto 365 days
Incidence of All-cause Death
Death from any cause during follow-up.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From index hospitalization for acute myocardial infarction, upto 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Sep 2014
- Primary completion30 Jun 2022
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp., Health Insurance Review & Assessment Service
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Principal investigator, Yonsei University Health System, Yongin Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198191
- Sponsor's protocol ID
- IRB No. 9-2023-0049
- Acronym
- SGLT2i-AMI
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study uses de-identified claims data from the Korean National Health Insurance Service (NHIS). Individual participant data cannot be shared because data access is restricted by NHIS regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07198191
- Acronym / sponsor ID
- SGLT2i-AMI / IRB No. 9-2023-0049
- Keywords
- SGLT2 inhibitor, Dapagliflozin, Empagliflozin, DPP4 inhibitor, Cardiovascular Outcomes, Heart Failure, Real-world Evidence, NHIS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp., Health Insurance Review & Assessment Service
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 provided important insights. In DAPA-MI, approximately 1 year of dapagliflozin therapy in patients with recent AMI improved cardiometabolic outcomes but did not reduce the composite endpoint of cardiovascular death or hospitalization for heart failure compared with placebo. Similarly, in EMPACT-MI, treatment with empagliflozin among high-risk patients following AMI did not significantly lower the risk of first hospitalization for heart failure or all-cause death compared with placebo. These findings highlight the need for complementary large-scale real-world data to further clarify the clinical utility of SGLT2 inhibitors in this population.
This investigator-initiated observational cohort study utilizes de-identified claims data from the Korean National Health Insurance Service (NHIS) to evaluate clinical outcomes associated with SGLT2 inhibitor use in patients with type 2 diabetes mellitus (T2DM) after AMI. The study population includes adult patients (≥19 years) hospitalized with AMI (ICD-10 codes I21-I23) between September 2014 and June 2021. Patients are stratified based on use of SGLT2 inhibitors versus dipeptidyl peptidase-4 (DPP4) inhibitors following the index event. Exclusion criteria include prior SGLT2 inhibitor use within 12 months before AMI, malignancy, cardiogenic shock, or missing ICD-10 data.
Outcomes of interest include major adverse cardiovascular events (all-cause mortality, cardiovascular death, recurrent MI, ischemic stroke) and bleeding events (major bleeding, site-specific bleeding, transfusion). Propensity-score matching is performed to adjust for baseline demographic and clinical characteristics. Kaplan-Meier survival curves and Cox proportional hazards models are used to estimate hazard ratios for outcomes.
The primary endpoint is the incidence of major adverse cardiovascular events (MACE). Secondary endpoints include individual cardiovascular events, hospitalization for heart failure, and bleeding events. Subgroup analyses assess outcomes according to comorbid chronic heart failure, chronic kidney disease, and concomitant thiazolidinedione therapy.
This study provides real-world evidence on the effectiveness and safety of SGLT2 inhibitors in routine clinical practice following AMI among patients with T2DM in Korea, thereby complementing randomized trial data and informing guideline recommendations for this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 Inhibitor Group | – | Drug: SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)Patients with type 2 diabetes mellitus (T2DM) who were prescribed SGLT2 inhibitors after acute myocardial infarction. |
| DPP4 Inhibitor Group | – | Drug: DPP4 inhibitorsPatients with type 2 diabetes mellitus (T2DM) who were prescribed DPP4 inhibitors after acute myocardial infarction. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥19 years) with type 2 diabetes mellitus who were hospitalized for acute myocardial infarction in South Korea between September 2014 and June 2021. Eligible patients were identified from the Korean National Health Insurance Service database, with follow-up available through June 2022.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)Exposure to SGLT2 inhibitors following AMI in patients with T2DM | Drug | SGLT2 Inhibitor Group |
| DPP4 inhibitorsExposure to DPP4 inhibitors following AMI in patients with T2DM | Drug | DPP4 Inhibitor Group |
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: From index date (hospitalization for AMI), upto 365 days
MACE defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke.
5 secondary outcomes
Incidence of Cardiovascular Death
Time frame: From index hospitalization for acute myocardial infarction, upto 365 days
Incidence of All-cause Death
Time frame: From index hospitalization for acute myocardial infarction, upto 365 days
Incidence of Non-fatal Myocardial Infarction
Time frame: From index hospitalization for acute myocardial infarction, upto 365 days
Incidence of Non-fatal Ischemic Stroke
Time frame: From index hospitalization for acute myocardial infarction, upto 365 days
Incidence of Hospital Admission for Heart Failure
Time frame: From index hospitalization for acute myocardial infarction, upto 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No. The study uses de-identified claims data from the Korean National Health Insurance Service (NHIS). Individual participant data cannot be shared because data access is restricted by NHIS regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongcheol Kim, MD, PhD principal investigator
Yonsei University Health System, Yongin Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction (AMI) and Type 2 Diabetes Mellitus (T2DM), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: From index date (hospitalization for AMI), upto 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.