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Evolocumab in Acute Coronary Syndrome
Sponsor: Johns Hopkins University
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.
Official title: Evolocumab in Acute Coronary Syndrome: A Double-Blind Randomized Placebo Controlled Study
Key Details
Gender
All
Age Range
25 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2018-05-20
Completion Date
2025-03-25
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Evolocumab
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Locations (1)
Steven Paul Schulman
Baltimore, Maryland, United States