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 \[STEMI\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6,019
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Eastern Shore Research Institute
Fairhope, Alabama, United States
Heart Center Research LLC
Huntsville, Alabama, United States
Northern Arizona Healthcare Corporation Cardiovascular Institute
Flagstaff, Arizona, United States
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona, United States
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Percentage Change From Baseline in LDL-C
Percent LDL-C change from baseline to 12 weeks in a subset of approximately 300 randomly selected participants.
Time frame: From Baseline to Week 12
Percentage Change From Baseline in LDL-C
Percent LDL-C change from baseline to 52 weeks in a subset of approximately 300 randomly selected participants.
Time frame: From Baseline to Week 52
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and cardiovascular death
Time frame: 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
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Total Myocardial Infarctions Events
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Total Arterial Revascularization Procedures
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Total Ischemia-driven Coronary Revascularization Procedures
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Total Ischemic Strokes
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Time to Cardiovascular Death
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
Time to All-Cause Death
Time frame: From Baseline to End of Study (Approximately 3.5 Years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pima Heart and Vascular Clinical Research
Tucson, Arizona, United States
John Muir Health and Cardiovascular Institute
Concord, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California-Irvine
Orange, California, United States
...and 110 more locations