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

NCT ID: NCT05887830

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Anterior ST Segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional drug 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.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Single administration of Nivolumab on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. 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.

Placebo treatment group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Single administration of Placebo on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. 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.

Interventions

Nivolumab

Single administration of Nivolumab on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. 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.

Intervention Type: DRUG

Placebo

Single administration of Placebo on the third day of revascularization after acute anterior ST segment elevation myocardial infarction. 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinyang Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Central Contacts

Yinchuan Xu, PhD

Role: CONTACT

lsyrmxyc@126.com

86-13968126628

Changle Ke, PhD

Role: CONTACT

keheart@zju.edu.cn

86-15757102667

Other Identifiers

YAN2023-0193

Identifier Type: -

Identifier Source: org_study_id