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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001065-17 | EudraCT Number |
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The sponsor required early termination of the economic agreement due to a supposed extension of the enrollment period for bureaucracy reasons and for the concomitant Covid -19 Pandemic
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| Name | Class |
|---|---|
| Centro Cardiologico Monzino | OTHER |
| Ospedale Bassini Cinisello Balsamo | UNKNOWN |
| Azienda Ospedaliera Ordine Mauriziano di Torino | OTHER |
| Ospedale Policlinico San Martino |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolocumab | Experimental | Evolocumab administration in the acute phase of ST elevation myocardial infarction |
|
| Standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Biological | Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Pavia | PV | 27100 | Italy |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
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| OTHER |
| Fondazione Poliambulanza Istituto Ospedaliero | OTHER |
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
| Azienda Ospedaliera Sant'Anna e San Sebastiano | OTHER |
| Azienda Ospedaliera, Ospedale Civile di Legnano | OTHER |
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|
| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |