EVOLVE-MI:EVOLocumab Very Early after Myocardial Infarction (EVOLVE-MI)
EVOLVE-MI: A Pragmatic Randomized Multicenter Trial of EVOLocumab Administered Very Early to Reduce the Risk of Cardiovascular Events in Patients Hospitalized With Acute Myocardial Infarction
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).
Evolocumab is a monoclonal antibody that targets the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation, reducing the liver's ability to remove LDL-cholesterol (LDL-C), or "bad" cholesterol, from the blood. Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface, resulting in more LDL receptors on the surface of the liver to remove LDL-C from the blood.
EVOLVE-MI is a multi-center, randomized, open-label, and event driven study investigating the effect of Evolocumab (brand name Repatha) as an intervention in patients who have recently been hospitalized for an acute Myocardial Infarction. Repatha is an FDA approved monoclonal antibody that targets the proprotein convertase subtilisin/Kexin type 9 (PCSK9), the protein that targets low density lipoprotein (LDL) receptors, reducing the liver’s ability to remove LDL cholesterol from the blood. Evolocumab binds to and inhibits the PCSK9 from binding to LDL receptors on the liver’s surface, in turn allowing more receptors on the surface to remove LDL cholesterol from the blood. Although Evolocumab (Repatha) has already been approved by the U.S. Food and Drug Administration and has shown promising lipid lowering effects, the effects of Evolocumab shortly after acute Myocardial Infarction has yet to be investigated.
The primary objective of Evolocumab administration very early after Myocardial Infarction is to evaluate the effectiveness of treatment with Evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce MI, ischemic stroke and arterial revascularization. As EVOLVE-MI is an open-label study, patients will be aware of whether they are randomized to the treatment, or standard care arm. Those in the standard care arm will continue with routine lipid management. Key Inclusion criteria include informed consent from the patient, age over 18 years, and hospitalization of either STEMI or NSTEMI due to presumed atherosclerotic disease. Key exclusion criteria include subjects with elevated biomarkers of myocardial injury due to secondary etiology (sepsis, atrial fibrillation, etc.), subjects requiring invasive hemodynamic and/or vasopressor/inotropic support at time of screening, history or evidence of clinically significant disease or unstable disorder that in the opinion of the investigator, may cause harm to the participant, or receiving other PCSK9 inhibitor therapies (Inclisiran 6 months prior or other PCSK9 therapy within 3 months of screening). The patient must be enrolled into EVOLVE-MI within 10 days of when the Myocardial Infarction took place.
Participants will be randomized in a 1:1 fashion to receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management vs standard of care routine lipid management as determined by primary treating physician.
Primary Outcome Measures :