EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS)
Status:
Completed
Trial end date:
2019-08-07
Target enrollment:
Participant gender:
Summary
Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk
of adverse events in patients with established atherosclerotic cardiovascular disease. The
clinical benefit of statins in improving clinical outcomes is proportional to the magnitude
of LDL-C reduction, is more pronounced in patients with acute coronary syndromes (ACS)
compared with stable coronary artery disease, and emerges at very early stages (as early as 4
weeks) after ACS when statins are administered in the acute phase of the event. On the basis
of this evidence, early initiation of statin therapy is currently recommended in patients
presenting with ACS. Because many patients cannot achieve adequate reduction of LDL-C levels
despite treatment with high doses of statins or non-statin lipid-modifying medications,
substantial residual risk remains. Moreover, the time of onset of LDL-C reduction takes 2
weeks following initiation of statin therapy. Proprotein convertase subtilisin/kexin type-9
(PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid,
profound, and consistent reductions in LDL-C levels. While the effectiveness of PCSK9
monoclonal antibodies for LDL-C lowering has been established across patient populations
without atherosclerotic cardiovascular disease or with stable ischemic heart disease,
reduction and attainment of LDL-C target levels has not been explored in the acute setting of
ACS - a clinical setting with highest risk of early event recurrence (within the first
month). In this study the investigators want to evaluate the safety and effectiveness of the
PCSK9 inhibitor evolocumab as compared with placebo, administered in the acute phase of ACS,
for reduction of LDL-C levels within 8 weeks in patients receiving guideline-recommended
high-intensity statin treatment (atorvastatin 40mg QD).