|Trial||Evolocumab in Acute Coronary Syndrome (EVACS)
ClinicalTrials.gov Identifier: NCT03515304
|Aim||To evaluate 1) low-density lipoprotein cholesterol (LDL-C) reduction during hospitalization and at 30 days, (2) changes in vascular/plaque and myocardial inflammation at 30 days, (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 6 months.|
|Study design||Randomized, double-blind, parallel-group placebo-controlled trial with quadruple masking (subject, care provider, investigator, outcomes assessor)
420 mg evolocumab will be administered subcutaneously using an autoinjector/pen in Non-ST segment elevation myocardial infarction (NSTEMI) patients within 24 hours, or one day, of hospital admission.
|Patient population||Acute coronary syndrome (ACS); NSTEMI; Troponin I >/ 5.0 ng/dL|
|Primary efficacy endpoint||The mean percent change from baseline in LDL-C comparing placebo and evolocumab groups at 30 days|
Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the aorta and / or carotid artery between the two treatment groups.