Ignite Creation Date:
2024-05-06 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03515304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2018-04-10
Brief Title:
Evolocumab in Acute Coronary Syndrome
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Evolocumab in Acute Coronary Syndrome A Double-Blind 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
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 an important subset of ACS patients those with non-ST elevation myocardial infarction NSTEMI by markedly reducing LDL-C stabilizing vulnerable plaque and limiting inflammation-associated myocardial cell loss and resultant dysfunction
Detailed Description:
In a placebo-controlled randomized double blind trial the addition of evolocumab to standard care in NSTEMI patients 1 decreases LDL-C during hospitalization and at 30 days 2 decreases vascularplaque and myocardial inflammation as assessed by Positron Emission Tomography PET scanning at 30 days and improves 3 serum markers of endothelial function at hospital discharge and at 30 days and 4 echocardiographic assessment of left ventricular function at 30 days and six months
This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation all of which may significantly impact important clinical outcomes in this high risk patient cohort
This is the first PCSK9 inhibitor trial which examines these outcomes in the ACS patient population It will provide valuable data on the extent and time course of LDL-C reduction as well as the impact of inhibition on inflammatory markers and on imaging assessment of vascular and myocardial inflammation all of which may significantly impact important clinical outcomes in this high risk patient cohort
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?:
None
Is an FDA AA801 Violation?:
None