Evaluating dapagliflozin's effect on patients with acute myocardial infarction

The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction

This study is testing if the medication dapagliflozin can help people who have had a heart attack and also have diabetes or high blood sugar to avoid serious heart problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Qingdao Central Hospital (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT05050500 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of dapagliflozin, an SGLT-2 inhibitor, on the short-term prognosis of patients diagnosed with acute myocardial infarction (MI). It aims to determine whether dapagliflozin can reduce the incidence of major adverse cardiovascular events (MACEs) in patients who have either STEMI or NSTEMI and have a history of type 2 diabetes or glucose intolerance. Participants will receive either dapagliflozin or a placebo, and their outcomes will be monitored over a specified period. The study is designed to fill the gap in knowledge regarding the effectiveness of dapagliflozin in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with acute myocardial infarction within the last 7 days who also have type 2 diabetes or glucose intolerance.

Not a fit: Patients with type 1 diabetes, renal dysfunction, or those who are hemodynamically unstable may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to improve outcomes for patients suffering from acute myocardial infarction.

How similar studies have performed: Previous studies have shown that SGLT-2 inhibitors can reduce cardiovascular events, suggesting potential success for this approach, although this specific application is less tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with acute MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
2. Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.

Exclusion Criteria:

1. Patients diagnosed with Type 1 Diabetes Mellitus.
2. Patients with renal dysfunction. (GFR\<90mmol/L).
3. Patients who have recently undergone immunosuppressive therapy.
4. Patients with a history of recurrent urinary tract infections.
5. Patients who are known to be allergic to SGLT-2 inhibitors.
6. Patients who are hemodynamically unstable.
7. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
9. Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Where this trial is running

Qingdao, Shandong

• Mengmei Li — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Mengmei Li, MD

Conditions Myocardial Infarction; Diabete Type 2; Glucose Intolerance; myocardial infarction; dapagliflozin; MACE events