Overview
Evolocumab in Acute Coronary Syndrome
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-01-15
2022-01-15
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Johns Hopkins UniversityCollaborators:
Amgen
Washington University School of MedicineTreatments:
Antibodies, Monoclonal
Evolocumab
Criteria
Inclusion Criteria:- 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