Viewing Study NCT04082442



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Last Modification Date: 2024-10-26 @ 1:17 PM
Study NCT ID: NCT04082442
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-05-09
First Post: 2019-09-05

Brief Title: Evolocumab in Patients With Acute MI
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Evolocumab in Patients With Acute Myocardial Infarction A Double-blind Prospective Randomized Placebo-Controlled Study
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-05
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: EVACS II
Brief Summary: Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome ACS patients are closely correlated to LDL-C levels and are associated with these adverse consequences in the post-ACS patient population Serum proprotein convertase subtilisinkerin type 9 PCSK9 levels are also increased in ACS may raise LDL-C and the investigators pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation The addition of the PCSK9 antibody evolocumab currently approved to lower LDL-C in certain patient populations to current medical therapies would appear to be of particular benefit in patients with an ACS by markedly reducing LDL-C stabilizing vulnerable plaque and limiting inflammation-associated myocardial cell loss and resultant dysfunction
Detailed Description: Despite aggressive early intervention and current secondary prevention strategies many patients who survive hospitalization for an acute coronary syndrome ACS experience subsequent unfavorable outcomes including recurrent ischemic events and unfavorable cardiac remodeling associated with progressive left ventricular dysfunction and congestive heart failure Vascular and myocardial inflammation are significantly increased in ACS patients are closely correlated with LDL-C levels and are associated with these adverse consequences Serum proprotein convertase subtilisinkerin type 9 PCSK9 levels are also increased in patients with ACS may raise LDL-C and the investigators pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation The addition of evolocumab to current medical therapies may therefore be of particular benefit in these patients by markedly reducing LDL-C stabilizing vulnerable plaque and limiting inflammation-associated myocardial cell loss and resultant dysfunction

In this study the investigators propose to test the effects of PCSK9 inhibition with evolocumab on LDL-C reduction vascular and myocardial inflammation cardiac function and clinical outcomes in an ACS patient cohort

The investigators propose a double-blind randomized study of 100 patients presenting with an ACS ST-Elevation- and Non-ST-elevation myocardial infarction One hundred ACS patients will be randomized to evolocumab 420 mg or to placebo 50 in each group during early hospitalization and will also receive current guideline-directed ACS therapy Lipid profiles including LDL-cholesterol levels and traditional and novel serum markers of inflammation and endothelial function will be measured at presentation during the index hospitalization and at 30-day and six-month follow-up Positron Emission Tomography PET scans to measure myocardial and vascular inflammation and echocardiograms will be performed during the early post-infarction period and at thirty days PET and echocardiogram and six-month echocardiogram following randomization Clinical outcomes such as angina class will also be collected at the six-month follow-up visit

The protocol and the primary and secondary lipid and inflammatory outcomes in this study are identical to those in NCT03515304 and therefore the data in the two studies may be analyzed together

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None