EVOLOCUMAB for Acute myocardial infarction (NSTEMI and STEMI)|Dyslipidemia|Hypercholesterolemia

Inclusion criteria

• {"criterion_text":"- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures; OR, subject’s legally authorized representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.\n- Age ≥ 18 years (eg, if no upper age limit).\n- Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease."}

Exclusion criteria

• {"criterion_text":"- Patients requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening\n- Subject has known sensitivity to any of the products or components to be administered during dosing.\n- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.\n- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n- Patients with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy).\n- History or evidence of clinically significant disease (eg, malignancy, respiratory, gastrointestinal, renal or psychiatric disease) or unstable disorder that, in the opinion of the investigator(s), Amgen physician or designee would pose a risk to the patient’s safety or interfere with the study assessments, procedures, completion, or result in a life expectancy of less than 1 year.\n- Previously received or receiving any therapy to inhibit PCSK9 in the following timeframe: • Evolocumab, alirocumab, or any other monoclonal antibody against PCSK9 within 3 months prior to screening. • Inclisiran within 6 months prior to screening.\n- Currently receiving treatment in another investigational (not approved for any use in the country the subject is to be randomized) device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n- Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 15 weeks after the last dose of investigational product.\n- Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product.\n- Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product.\n- Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test."}

Primary endpoints

• {"endpoint_text":"- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death.","definition_or_measurement_approach":"Composite endpoint of first and subsequent events including myocardial infarction, ischemic stroke, arterial revascularization procedures, and all-cause death; measured as occurrence of these clinical events (time-to-event not explicitly specified in the endpoint description)."}

Secondary endpoints

• {"endpoint_text":"- Percent LDL-C change from baseline to 12 weeks and 52 week in a subset of approximately 300 selected subjects.","definition_or_measurement_approach":"Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline measured at 12 weeks and 52 weeks in a subset (~300 subjects)."}
• {"endpoint_text":"- Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death.","definition_or_measurement_approach":"Composite clinical endpoint including myocardial infarction, ischemic stroke, arterial revascularization, and cardiovascular death; measured as total (first and subsequent) events."}
• {"endpoint_text":"- Time to the first occurrence of the composite of myocardial infarction, ischemic stroke, revascularization procedure, and all-cause death.","definition_or_measurement_approach":"Time-to-first occurrence of the composite of MI, ischemic stroke, revascularization, and all-cause death."}
• {"endpoint_text":"- Total myocardial infarctions","definition_or_measurement_approach":"Count of total myocardial infarction events."}
• {"endpoint_text":"- Total arterial revascularization procedures","definition_or_measurement_approach":"Count of total arterial revascularization procedures."}
• {"endpoint_text":"- Total ischemia-driven coronary revascularization procedures","definition_or_measurement_approach":"Count of ischemia-driven coronary revascularization procedures."}
• {"endpoint_text":"- Total ischemic strokes","definition_or_measurement_approach":"Count of ischemic stroke events."}
• {"endpoint_text":"- Cardiovascular death","definition_or_measurement_approach":"Occurrence of death due to cardiovascular causes."}
• {"endpoint_text":"- All-cause death","definition_or_measurement_approach":"Occurrence of death from any cause."}

Sweden

Earliest CTIS Part Ii Submission Date

17-01-2024

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

799

Number Of Sites

15

Number Of Participants

700

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States