Reperfusion Injury, Myocardial Clinical Trial
Official title:
Effectiveness of Empagliflozin on Cardiac-renal Injury in Patients With Acute ST-segment-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention.
This study is a single-center, prospective controlled trial addressing effectiveness of
empagliflozin on cardiac-renal injury in patients with STEMI. Patients were randomized using
a computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio.
Investigators, participants, and other study personnel were blinded to the assigned treatment
for the duration of the study. The primary objective of this study is to investigate the
effects of empagliflozin on myocardial infarct size measured using cardiac magnetic resonance
(CMR) methods at 3 months. Key secondary endpoint: incidence of CIAKI within 48h after PCI.
Inclusion Criteria:Patients with STEMI who were admitted to the Chinese PLA General Hospital
were recruited between Ocotor 2018 and January 2019. STEMI was defined as typical chest pain
lasting >30 minutes within the previous 12 hours, a clear ST-segment elevation of >0.1 mV in
two or more contiguous electrocardiographic leads, and elevated blood levels of troponin
T.Exclusion Criteria:Cardiogenic shock ,Hypoglycaemia ,Diabetic ketoacidosis,Genital and
urinary infections,History of myocardial infarction,Stent thrombosis,Previous coronary artery
bypass surgery,Type 1 Diabetes,Severe hepatic insufficiency,Advanced cancer patients,eGFR<30
ml/min.
All patients were informed of the potential risks (genital mycotic infections, urinary tract
infections, diabetic ketoacidosis) associated with empagliflozin and then required to submit
written informed consent before being included in the study. Patients were randomized using a
computer-generated sequence to either placebo or empagliflozin at a 1:1 ratio. Patients in
the empagliflozin group were treated with empagliflozin whereas patients in the control group
were given placebo. The treatment started 30 minutes before PCI with a dose of 10 mg
empagliflozin or placebo administered in the ambulance. After admission, patients were
treated with 10 mg empagliflozin once daily for 3 mouths.
n/a
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