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

NCT05887830 | Unknown Phase 1 DMC

• 1 other identifier: YAN2023-0193
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Anterior ST Segment Elevation Myocardial Infarction

Keywords

Nivolumab; acute anterior ST segment elevation myocardial infarction

Outcome Measures

Primary Outcomes (2)

• ∆Infarct size/Left Ventricular mass%

  Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.

  3 months

• The incidence of adverse events

  The incidence of adverse events during 3 months after Nivolumab treatment.

  up to 3 months

Secondary Outcomes (5)

• ∆Left ventricle ejection fraction%

  3 months

• ∆Left ventricle end systolic volume/Body surface area

  3 months

• ∆Left ventricle end diastolic volume/Body surface area

  3 months

• ∆Troponin T

  3 months

• ∆proBNP

  3 months

Study Arms (2)

Interventional drug treatment group

EXPERIMENTAL

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.

Drug: Nivolumab

Placebo treatment group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Nivolumab 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.

Interventional drug treatment group

Placebo 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.

Placebo treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xinyang Hu, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinchuan Xu, PhD

CONTACT

86-13968126628; lsyrmxyc@126.com

Changle Ke, PhD

CONTACT

86-15757102667; keheart@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: June 15, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share