Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 2/17/2018 |
| Start Date: | February 8, 2013 |
| End Date: | November 11, 2016 |
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
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