Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
Acute Anterior ST Segment Elevation Myocardial Infarction
About this trial
This is an interventional treatment trial for Acute Anterior ST Segment Elevation Myocardial Infarction focused on measuring Nivolumab, acute anterior ST segment elevation myocardial infarction
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years; Signed informed consent and expected compliance with protocol; Acute anterior ST segment elevation myocardial infarction; Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset; Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization. Exclusion Criteria: Cardiogenic shock; Cardiac arrest/ventricular fibrillation; History of severe renal failure, glomerular filtration rate (eGFR) < 30ml/min; History of severe infection, hepatobiliary obstruction or malignant tumor; Receiving immunosuppressive therapy; Women who are pregnant or may become pregnant; There are contraindications to study drugs or magnetic resonance examination; No written informed consent was obtained.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Interventional drug treatment group
Placebo treatment group
The participants receive Nivolumab treatment. The active drug Nivolumab will be administered at a standard dose (5mg/kg) dissolved in 100ml 0.9%NaCl solution. Nivolumab was given at a rate of 15-25 drops per minute, and the intravenous infusion time exceeded 1 hour.
The participants receive placebo treatment. Patients assigned to the placebo treatment group will receive an intravenous infusion of 100 ml 0.9% NaCl solution at a rate of 15-25 drops/min for an IV infusion duration of more than 1 hour.