Completed

Dapagliflozin Impact on Acute Myocardial Infarction in Type 2 Diabetes

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Study Aim

This study aims to evaluate the effects of Dapagliflozin treatment on acute myocardial infarction in individuals with type 2 diabetes.

What is being tested

Dapagliflozin 10mg/Tab

+ control group

Drug
Who is being recruted

Cardiovascular Diseases+15

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorQingdao Central Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 8, 2023

Actual date on which the first participant was enrolled.

This study focuses on a medication called Dapagliflozin, which belongs to a group of drugs known as SGLT-2 inhibitors. These drugs have shown promise in treating heart failure. However, their effects on myocardial infarction, a common condition leading to death, are not fully understood. The study aims to investigate how Dapagliflozin might impact the short-term recovery of patients who have experienced a heart attack, as compared to a placebo. The potential outcomes of this research could provide valuable insights into improving care for heart attack patients and addressing current treatment challenges. During the study, participants will receive either Dapagliflozin or a placebo. The study will measure changes in heart function, specifically the left ventricular ejection fraction, left ventricle end-systolic volume, and left ventricular end-diastolic volume. These measurements help evaluate the heart's pumping efficiency. The study also monitors major adverse cardiovascular events (MACEs), such as heart attacks, strokes, and cardiovascular deaths. Additionally, it assesses the occurrence of post-infarction angina and the development of new-onset heart failure during the study period. The results of these measurements will help determine the potential benefits and risks of Dapagliflozin for heart attack patients.

Official TitleEffects of Dapagliflozin on Inflammatory Factorslevel and Prognosis in Type 2 Diabetes With Acute Myocardial Infarction
NCT05050500
Principal SponsorQingdao Central Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

143 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHeart DiseasesHyperglycemiaInfarctionIschemiaMetabolic DiseasesMyocardial InfarctionNecrosisNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaGlucose IntoleranceGlucose Metabolism Disorders

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group will receive Dapagliflozin, a medication, in a dose of 10 mg every 24 hours for a period of 12 months.

Group II

Participants in this group receive the standard therapy for Acute Myocardial Infarction (AMI) every 24 hours for 12 months. This is the current standard treatment, not a new or experimental one.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mengmei Li

Qingdao, ChinaOpen Mengmei Li in Google Maps
CompletedOne Study Center