The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5,035
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Time frame: Up to 5 years
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time frame: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time frame: Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
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Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Banning, California, United States
Research Site
Long Beach, California, United States
Research Site
Oceanside, California, United States
Research Site
Oxnard, California, United States
Research Site
Palm Springs, California, United States
Research Site
Roseville, California, United States
Research Site
San Diego, California, United States
...and 188 more locations