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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Nivolumab

Criteria

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.