This is a prospective, multi-centre, open label, randomised study of Phase II that enrolls patients hospitalized with a diagnosis of ST-elevation myocardial infarction (STEMI), comparing Evolocumab versus Standard of Care.
Primary objective of the study is to assess whether early evolocumab administration reduces infarct size in patients with STEMI undergoing primary PCI. At least 150 patients will be enrolled to investigate the efficacy and safety of evolocumab administration in the acute phase of STEMI. Patients will be followed for 1 year after the enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)
IRCCS Policlinico San Matteo
Pavia, PV, Italy
Infarct Size reduces infarct size in patients with STEMI undergoing primary PCI
• Myocardial salvage index (MSI) at 6 months evaluated with cardiac magnetic resonance (CMR)
Time frame: 6 months Visit
Inflammatory Cytokine Response
Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor
Time frame: 6 months Visit
Cholesterol LDL levels
Absolute and percentage changes in c-LDL levels
Time frame: 6 months Visit
Major adverse cardiovascular events
Rate of composite cardiovascular death, MI or stroke
Time frame: 12 months Visit
Euroqol 5-dimension questionnaire
Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100)
Time frame: 12 months Visit
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