Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)

Conditions
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ST-elevation Myocardial Infarction

Intervention / Treatment
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* Biological: Evolocumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Chest pain or equivalent lasting > 20 minutes ST elevation myocardial infarction scheduled for primary PCI Signed written informed consent Exclusion Criteria: Previous myocardial infarction Previous percutaneous or surgical myocardial revascularization Ongoing treatment with any statin or ezetimibe History of congestive heart failure Cardiogenic shock at presentation Known Pregnancy Women of Childbearing Age Known major active infection or major hematologic, renal, hepatic, or endocrine dysfunction Malignancy (except non-melanoma skin cancer, cervical in situ carcinoma, breast ductal carcinoma in situ, stage 1 prostate carcinoma) within the last 10 years Patients with hypersensitivity to the active substance (evolocumab) or to any of its excipients Inability to attend the scheduled clinical evaluation and laboratory tests Inability to undergo the pharmacological treatment or other procedures of the study Currently enrolled in another investigational drug study, or < 30 days/<5 half-life since ending another investigational drug study(s).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolocumab<br>Evolocumab administration in the acute phase of ST elevation myocardial infarction | Biological: Evolocumab<br>* Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)<br>* Other names: Repatha;|
| No Intervention: Standard of care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Cytokine Response | Absolute changes of hs-C reactive protein, Interleukin 1, 6 and10, and alfa Tumor Necrosis Factor | 6 months Visit | 
| Cholesterol LDL levels | Absolute and percentage changes in c-LDL levels | 6 months Visit | 
| Major adverse cardiovascular events | Rate of composite cardiovascular death, MI or stroke | 12 months Visit | 
| Euroqol 5-dimension questionnaire | Euroqol 5-dimension questionnaire (minimum value 0, and maximum value 100) | 12 months Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Percutaneous Coronary Intervention, Evolocumab, Cardiac Magnetic Resonance