CompletedPhase 4

Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients With Acute Myocardial Infarction

Indonesia40 participantsStarted 2024-09-21

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Patients with cardiogenic shock (SBP ≤ 80 mmHg, cold extremities, urine output \<0.5 ml/kg/hr) \<24 hours before randomization
. Patients with ketoacidosis (arterial pH \<7.30, serum bicarbonate \<18 mEq/l, positive ketonuria)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Biomolecular Parameters

Timeframe: 14 days

Trial details

NCT IDNCT06615674

SponsorYoga Yudhistira

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Acute Myocardial Infarction (AMI) trials