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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01764633RENIS: IS000384Tipo: INTERVENTIONALInicio: 8 de feb de 2013Fin estimado: 11 de nov de 2016

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

biological

Evolocumab

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

drug

Placebo

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.