Dyslipidemia MedDRA version: 21.0 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen
Product Name: Evolocumab, prefilled autoinjector pen (AI/pen)
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: - 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. - Age = 18 years (eg, if no upper age limit). - Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1780
Exclusion criteria
Exclusion criteria: Disease Related - Patients requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening - 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).). Other Medical Conditions - 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. Prior/Concomitant Therapy - 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. Prior/Concurrent Clinical Study Experience 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. Other Exclusions - 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. - Female subjects who are breastfeeding or who plan to breastfeed while on study through 15 weeks after the last dose of investigational product. - Female subjects planning to become pregnant while on study through 15 weeks after the last dose of investigational product. - Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive urine or serum pregnancy test. - Subject has known sensitivity to any of the products or components to be administered during dosing. - 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness of treatment with evolocumab plus routine lipid management compared with routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization and all-cause death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI).;Secondary Objective: To evaluate the effectiveness of treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting on percent reduction of low-density lipoprotein cholesterol (LDL-C) at 12 weeks and 52 weeks following initiation. To evaluate the effectiveness of treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and cardiovascular death in subjects hospitalized for an acute myocardial infarction (NSTEMI and STEMI). To evaluate the effect of treatment with evolocumab plus routine lipid management vs routine lipid management alone on the risk of: - first myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death.;Primary end point(s): Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death.;Timepoint(s) of evaluation of this end point: 3.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent LDL-C change from baseline to 12 weeks and 52 week in a subset of approximately 300 selected subjects. • Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death. • Time to the first occurrence of the composite of myocardial infarction, ischemic stroke, revascularization procedure, and all-cause death. • Total myocardial infarctions • Total arterial revascularization procedures • Total ischemia-driven coronary revascularization procedures • Total ischemic strokes • Cardiovascular death • All-cause death;Timepoint(s) of evaluation of this end point: Baseline and each scheduled yearly visit | — |
Countries
Brazil, Sweden, United States
Contacts
Public ContactMedical Info - Clinical Trials
Amgen AB
Outcome results
None listed