Clinical trial NCT05887830: Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
Official title: Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Anterior ST Segment Elevation Myocardial Infarction
Keywords: Nivolumab
acute anterior ST segment elevation myocardial infarction
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: ∆Infarct size/Left Ventricular mass%
timeFrame: 3 months
measure: The incidence of adverse events
timeFrame: up to 3 months
Secondary outcomes:
measure: ∆Left ventricle ejection fraction%
timeFrame: 3 months
measure: ∆Left ventricle end systolic volume/Body surface area
timeFrame: 3 months
measure: ∆Left ventricle end diastolic volume/Body surface area
timeFrame: 3 months
measure: ∆Troponin T
timeFrame: 3 months
measure: ∆proBNP
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Xinyang Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: