NCT06615674CompletedPhase 4
Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients With Acute Myocardial Infarction
The Effect of Dapagliflozin on the Apoptosis Levels of Patients With Acute Myocardial Infarction - DAPOPTOSIS-MI (a Randomized Controlled Trial)
Source: ClinicalTrials.gov · Last updated 27 Feb 2025
Brief summary (registry, in English)
The currently known Sodium-Glucose Transporter 2 (SGLT-2) inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects, including improvements in endothelial dysfunction, inhibition of platelet activation, reduction in autophagy processes, oxidative stress, and inflammation, as well as inhibition of the Na+/H+ exchanger pathway, which potentially reduces cell damage and death resulting from ischemia and reperfusion processes. Research on the benefits of SGLT-2 inhibitors in pre-clinical studies with myocardial infarction has shown a significant reduction in myocardial apoptosis, indicated by reduced levels of caspase-3 and the apoptosis index. Additionally, there was an increase in ketone bodies and myocardial ATP, reduced levels of inflammatory cytokines, free radicals, and infarct area, as well as improvements in left ventricular ejection fraction. However, large-scale studies in humans have thus far been limited to investigating the effects of SGLT-2 inhibitors on mortality, rehospitalization rates due to heart failure, cardiometabolic factors, and improvements in remodeling parameters in myocardial infarction patients, with the use of empagliflozin or dapagliflozin. Based on literature reviews, there have been no studies to date that directly demonstrate the effects of dapagliflozin on apoptosis (caspase-3 levels) in myocardial infarction patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 21 Sept 2024
- Start date
- 21 Sept 2024
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Yoga Yudhistira
- Diseases
- Coronary artery disease
- NCT number
- NCT06615674
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 40
- From 21 Sept 2024 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for coronary artery bypass surgery
Other illness
- Patients with a history of chronic heart failure before the onset of Acute Myocardial Infarction
- Patients with type 1 diabetes mellitus
- Patients with severe valvular disease
- Patients with symptomatic acute urinary tract infection
Lab values
- Patients with ketoacidosis (arterial pH \<7.30, serum bicarbonate \<18 mEq/l, positive ketonuria)
- Patients with impaired renal function with an estimated glomerular filtration rate (eGFR) \<20 ml/min or requiring dialysis
Other
- Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hr) \<24 hours before randomization
- Patients with sepsis
- Pregnant patients
- Patients with severe aortic stenosis or LVOT obstruction
Who the study is looking for
- Patients with Acute Myocardial Infarction (STEMI or NSTEMI) according to the Fourth Universal Definition of Myocardial Infarction from the European Society of Cardiology, American College of Cardiology, American Heart Association, and World Heart Federation.
- Aged 18-75 years
- Willing to participate in the study and sign informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Moewardi General Hospital, Jebres, Surakarta, Central of Java, 57126 Coordinator of this site? Confirm its status | Surakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.