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

Last updated: September 15, 2023
Sponsor: Qingdao Central Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 2

Blood Clots

Diabetes Prevention

Treatment

Dapagliflozin 10mg/Tab

Placebo

Clinical Study ID

NCT05050500
DAFLO-CH
DAFLO
  • Ages 40-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 ejectionfraction (LVEF≤40 %), documented before the current MI hospitalization.
  8. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into thetrial.
  9. Any other non cardiovascular diseases, such as active malignancy requiring treatmentat the time of screening or with a life expectancy of fewer than two years based onthe investigator´s clinical judgment.
  10. Currently on treatment with a sodium-glucose co-transporter 2 inhibitor (SGLT2-inhibitor).

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Dapagliflozin 10mg/Tab
Phase: 4
Study Start date:
May 08, 2023
Estimated Completion Date:
January 30, 2026

Connect with a study center

  • Mengmei Li

    Qingdao, Shandong 266042
    China

    Active - Recruiting

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