Skip to main content
OpenTrials
Completed

NCT Number: NCT05050500

Effects of Dapagliflozin on Inflammatory Factorslevel and Prognosis in Type 2 Diabetes With Acute Myocardial Infarction

Dapagliflozin is one of the SGLT-2 inhibiters. Recent clinical trials have demonstrated that SGLT-2 inhibitors are effective for treating heart failure. The DAPA-HF clinical trial has demonstrated that the effects of empagliflozin and dapagliflozin improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF[1]. However, its effect on myocardial infarction, the most common disease leading to death in the population, has not been evaluated sufficiently. A meta-analysis has demonstrated that compared with the control, SGLT2 inhibitor is associated with a reduction in the incidence of major adverse cardiovascular events (MACEs), myocardial infarction, cardiovascular mortality and all-cause mortality[2]. It seems that dapagliflozin might be effective for patients with acute myocardial infarction based on these studies. Thus, this study aims to evaluate the effect of dapagliflozin on short-term prognosis in patients with acute myocardial infarction compared to placebo.

1. Faiez Zannad, João Pedro Ferreira, Stuart J Pocock et el. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829. 2. Cai-Yan Zou, Xue-Kui Liu, Yi-Quan Sang et el. Effects of SGLT2 inhibitors on cardiovascular outcomes and mortality in type 2 diabetes: A meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18245.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Heart Diseases Hyperglycemia Infarction Ischemia Metabolic Diseases Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mengmei Li

Qingdao, Shandong, 266042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Previously diagnosed with type2 diabetes mellitus, newly diagnosed type2 diabetes according to ADA criteria or glucose intolerance.
  • 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

  • Patients diagnosed with Type 1 Diabetes Mellitus.
  • Patients with renal dysfunction. (GFR<90mmol/L).
  • Patients who have recently undergone immunosuppressive therapy.
  • Patients with a history of recurrent urinary tract infections.
  • Patients who are known to be allergic to SGLT-2 inhibitors.
  • Patients who are hemodynamically unstable.
  • Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
  • Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
  • 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.
  • Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Treatment and study plan

Dapagliflozin 10mg/Tab

Drug

patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months

Other names: Dapagliflozin Group

Control group

Drug

patients meeting the inclusion criteria will be randomized to receive AMI standard therapy every 24 hours for 12 months.

Primary outcomes

  1. MACE events

    Time frame: 12 months

    To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes in post-infarction patients during the follow-up time.

  2. Post-infarction angina

    Time frame: 12 months

    Evaluate the post-infarction angina occurence in both groups

  3. The rate of heart failure occurrence

    Time frame: 12 months

    Assess the rate of new-onset heart failure during the study follow-up.

  4. IL-6

    Time frame: baseline, 1 month, 3 month, 6 month, 12 month

    Serum IL-6 level

Secondary outcomes

  1. IL-1β

    Time frame: baseline, 1 month, 3 month, 6 month, 12 month

    Serum IL-1β

  2. hs-CRP

    Time frame: baseline, 1 month, 3 month, 6 month, 12 month

    hs-CRP

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2021
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.