Cardiovascular Disease, Myocardial Infarction, Stroke, Coronary Revascularization
Conditions
Keywords
Acute Myocardial Infarction, Cardiovascular Disease, Stroke, Coronary revascularization, Evolocumab, STEMI, NSTEMI, Heart Attack, Pragmatic
Brief summary
The primary objective of this study is to evaluate the effectiveness of early 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 all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction \[NSTEMI\] and ST-segment elevation myocardial infarction \[STEMI\]).
Interventions
DRUGEvolocumab
Evolocumab will be provided as a single-dose, prefilled autoinjector pen (AI/pen) for fixed dose subcutaneous (SC) injection.
Routine lipid management therapies will be administered at the discretion of the investigator per SoC.
Sponsors
Colorado Prevention Center
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years * Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
Exclusion criteria
* Participants requiring invasive hemodynamic and/or vasopressor/inotropic support at the time of screening * Participants with elevated biomarkers of myocardial injury due to secondary/nonatherosclerotic etiology (eg, sepsis, atrial fibrillation, vasospasm, decompensated heart failure, uncontrolled hypertension, stress induced cardiomyopathy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death | From Baseline to End of Study (Approximately 3.5 Years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Time to the First Occurrence of the Composite of Myocardial Infarction, Ischemic Stroke, any Arterial Revascularization Procedure, and All-Cause Death | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Total Myocardial Infarctions Events | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Total Arterial Revascularization Procedures | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Percentage Change From Baseline in LDL-C | From Baseline to Week 12 | Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants. |
| Total Ischemic Strokes | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Time to Cardiovascular Death | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Time to All-Cause Death | From Baseline to End of Study (Approximately 3.5 Years) | — |
| Total Ischemia-driven Coronary Revascularization Procedures | From Baseline to End of Study (Approximately 3.5 Years) | — |
Countries
Brazil, Sweden, United States
Outcome results
None listed