A Phase 2 interventional study of Evolocumab in ST-elevation Myocardial Infarction, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Withdrawn at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Phase 2, Interventional, and Treatment
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.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
Browse ST Elevation Myocardial Infarction studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
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Exclusion Criteria:
Evolocumab administration in the acute phase of ST elevation myocardial infarction
Biological: Evolocumab
Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)
Also known as: Repatha
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
This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Evolocumab
ST Elevation Myocardial Infarction →
Fondazione IRCCS Policlinico San Matteo di Pavia →