Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial

Zhejiang University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Acute Anterior ST Segment Elevation Myocardial Infarction

Treatments: Other: Placebo; Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05887830

YAN2023-0193

Details and patient eligibility

About

Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.

Full description

The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 80 years;
2. Signed informed consent and expected compliance with protocol;
3. Acute anterior ST segment elevation myocardial infarction;
4. Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
5. Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.

Exclusion criteria

1. Cardiogenic shock;
2. Cardiac arrest/ventricular fibrillation;
3. History of severe renal failure, glomerular filtration rate (eGFR) < 30ml/min;
4. History of severe infection, hepatobiliary obstruction or malignant tumor;
5. Receiving immunosuppressive therapy;
6. Women who are pregnant or may become pregnant;
7. There are contraindications to study drugs or magnetic resonance examination;
8. No written informed consent was obtained.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups, including a placebo group

Interventional drug treatment group

Experimental group

Description:

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.

Treatment:

Drug: Nivolumab

Placebo treatment group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo