Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Completed · Phase 3 · Has a placebo group
Conditions studied: Dyslipidemia
In brief
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Key facts
- Study ID
- NCT01764633
- Run by
- Amgen
- People needed
- 27564
- Starts
- 2013-02-08
- Expected to finish
- 2016-11-11
- Last updated by the study team
- 2024-05-28
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female ≥ 40 to ≤ 85 years of age
- History of clinically evident cardiovascular disease at high risk for a recurrent event
- Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L)
- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
You may not qualify if…
- New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
- Uncontrolled hypertension
- Uncontrolled or recurrent ventricular tachycardia
- Untreated hyperthyroidism or hypothyroidism
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis
Where it is running
- Research Site — Birmingham, Alabama, United States
- Research Site — Huntsville, Alabama, United States
- Research Site — Mobile, Alabama, United States
- Research Site — Anchorage, Alaska, United States
- Research Site — Glendale, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Phoenix, Arizona, United States
- Research Site — Tucson, Arizona, United States
- Research Site — Tucson, Arizona, United States
- Research Site — Alhambra, California, United States
- Research Site — Banning, California, United States
- Research Site — Beverly Hills, California, United States
- Research Site — Encino, California, United States
- Research Site — Escondido, California, United States
- Research Site — Glendale, California, United States
- Research Site — Harbor City, California, United States
- Research Site — Huntington Beach, California, United States
- Research Site — Laguna Hills, California, United States
- Research Site — Long Beach, California, United States
- Research Site — Long Beach, California, United States
- Research Site — Los Alamitos, California, United States
- Research Site — Los Angeles, California, United States
- Research Site — Los Angeles, California, United States
- Research Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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