Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05887830
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-08
First Post:
2023-05-24
Brief Title:
Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction A Randomized Clinical Trial
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 randomized placebo-controlled open-label trial we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab 5mgkg for single administration or placebo The primary end points were difference in infarct sizeLV 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 LVESVBody surface area LVEDVBody surface area Trponin T and proBNP from baseline to 3 months after Nivolumab administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None