Evolocumab in Acute Coronary Syndrome

  • STATUS
    Recruiting
  • End date
    Aug 1, 2021
  • participants needed
    60
  • sponsor
    Johns Hopkins University
Updated on 6 January 2020
myocardial infarction
stemi
infarct
troponin

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 subtilisin/kerin 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.

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 vascular/plaque 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.

Details
Treatment Placebo, Evolocumab
Clinical Study IdentifierNCT03515304
SponsorJohns Hopkins University
Last Modified on6 January 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 25 yrs and 90 yrs?
Gender: Male or Female
Do you have Acute Coronary Syndrome?
Non ST segment elevation myocardial infarction
Troponin I >/ 5.0 ng/dL
Permission of attending physician

Exclusion Criteria

ST elevation myocardial infarction
Patients requiring invasive hemodynamic support
Scheduled for cardiac surgery
Current or prior treatment with a PCSK9 antibody
Current participation in an intervention clinical trial
Female of childbearing potential who has not used acceptable method(s) of birth control for at least one month prior to screening
Contraindication to statin therapy
Subject likely not able to complete protocol related visits or procedures
Latex allergy
History of hypersensitivity to any monoclonal antibody
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