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

Primary Purpose

Acute Anterior ST Segment Elevation Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nivolumab
Placebo
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Anterior ST Segment Elevation Myocardial Infarction focused on measuring Nivolumab, acute anterior ST segment elevation myocardial infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Interventional drug treatment group

    Placebo treatment group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    ∆Infarct size/Left Ventricular mass%
    Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.
    The incidence of adverse events
    The incidence of adverse events during 3 months after Nivolumab treatment.

    Secondary Outcome Measures

    ∆Left ventricle ejection fraction%
    Difference in Left ventricle ejection fraction% from baseline to 3 months after Nivolumab administration.
    ∆Left ventricle end systolic volume/Body surface area
    Difference in Left ventricle end systolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
    ∆Left ventricle end diastolic volume/Body surface area
    Difference in Left ventricle end diastolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
    ∆Troponin T
    Difference in concentration of Troponin T from baseline to 3 months after Nivolumab administration.
    ∆proBNP
    Difference in concentration of proBNP from baseline to 3 months after Nivolumab administration.

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    June 6, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887830
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Anterior ST Segment Elevation Myocardial Infarction
    Keywords
    Nivolumab, acute anterior ST segment elevation myocardial infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional drug treatment group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Placebo treatment group
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Nivolumab
    Intervention Description
    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
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    ∆Infarct size/Left Ventricular mass%
    Description
    Difference in Infarct size/Left ventricular mass% from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months
    Title
    The incidence of adverse events
    Description
    The incidence of adverse events during 3 months after Nivolumab treatment.
    Time Frame
    up to 3 months
    Secondary Outcome Measure Information:
    Title
    ∆Left ventricle ejection fraction%
    Description
    Difference in Left ventricle ejection fraction% from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months
    Title
    ∆Left ventricle end systolic volume/Body surface area
    Description
    Difference in Left ventricle end systolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months
    Title
    ∆Left ventricle end diastolic volume/Body surface area
    Description
    Difference in Left ventricle end diastolic volume/Body surface area from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months
    Title
    ∆Troponin T
    Description
    Difference in concentration of Troponin T from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months
    Title
    ∆proBNP
    Description
    Difference in concentration of proBNP from baseline to 3 months after Nivolumab administration.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yinchuan Xu, PhD
    Phone
    86-13968126628
    Email
    lsyrmxyc@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Changle Ke, PhD
    Phone
    86-15757102667
    Email
    keheart@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xinyang Hu, PhD
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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