ISGLT2 in Patients Without DM With Acute MI (NCT06903754) | Clinical Trial Compass
CompletedNot Applicable
ISGLT2 in Patients Without DM With Acute MI
Morocco450 participantsStarted 2021-10-01
Plain-language summary
This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.
Who can participate
SexALL
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Inclusion Criteria :
* Participant must approved the informed consent.
* Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
* Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with Ejection Fraction\<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
* Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).
Exclusion Criteria:
* Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
* Chronic symptomatic HF with a prior HHF within the last year and known reduced ejection fraction (LVEF≤40 %), documented before the current MI hospitalization.
* Patients with cardiogenic shock who received vasoactive drugs during index.
* Hospitalization Severe (eGFR \<20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
* Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
* Active malignancy requiring treatment at the time of screening.
* Any non-CV condition, eg malignancy, with a life expectancy of less than one years based on the investigator´s clinical judgement.
* Currently on treatment, or with an indication for treatment, with a sodium glucose co-transport…