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De klinische studie NCT07198191 (SGLT2i-AMI) voor Acuut myocardinfarct (AMI), Type 2 Diabetes Mellitus (T2DM) is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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SGLT2 Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Cohort Study (SGLT2i-AMI) 200.000 Real-world data Observationeel

Actief, niet rekruterend
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De klinische studie NCT07198191 (SGLT2i-AMI) is een observationeel studie bij Acuut myocardinfarct (AMI), Type 2 Diabetes Mellitus (T2DM) met de status actief, niet rekruterend. Het doel is om 200.000 deelnemers te includeren vanaf 1 september 2014. De studie wordt geleid door Yonsei-universiteit en de voltooiing is gepland op 30 augustus 2026. Laatste update op ClinicalTrials.gov: 30 september 2025.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel

Impact of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Use After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Nationwide Population Cohort Study

Aandoeningen
Acuut myocardinfarct (AMI)Type 2 Diabetes Mellitus (T2DM)
Andere studie-ID's
  • SGLT2i-AMI
  • IRB No. 9-2023-0049
NCT-ID
NCT07198191
Startdatum (Werkelijk)
2014-09-01
Laatste update geplaatst
2025-09-30
Verwachte einddatum
2026-08-30
Inschrijving (Geschat)
200.000
Studietype
Observationeel
Status
Actief, niet rekruterend
Trefwoorden
SGLT2 inhibitor
Dapagliflozin
Empagliflozin
DPP4 inhibitor
Cardiovascular Outcomes
Heart Failure
Real-world Evidence
NHIS
South Korea
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
19 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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 University logoYonsei-universiteit200 actieve klinische studies om te verkennen
  • Chong Kun Dang Pharmaceutical Corp. logoChong Kun Dang Pharmaceutical
  • Health Insurance Review & Assessment Service logoHealth Insurance Review & Assessment Service
Verantwoordelijke instantie
Yongcheol Kim, Hoofdonderzoeker, Principal Investigator, Yonsei University
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Gyeonggi-do

Yongin Severance Hospital, Yonsei University Health System, Yongin, Gyeonggi-do, 16995, South Korea