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

Fourier [NCT01764633]

Description: The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.

Biological: Evolocumab (AMG 145); Other: Placebo; Drug: Effective statin therapy

Primary Investigator: Kereiakes

Drug/Device Information
Impact of LDL reduction on CV events when AMG 145 is used in combination with statin therapy in pts with CV disease
AMG 145 - human monoclonal immunoglobulin (Ig) G2 that binds to PCSK9 and prevents the interaction of PCSK9 with LDLR
Randomized 1:1 to either receive AMG 145 or placebo SC
Amgen Inc
Major Inclusion and Exclusion
Age ≥ 40 to ≤ 85 AND history of clinically evident CV disease AND at least 1 major risk factor or 2 minor risk factors
No left ventricular ejection fraction < 30%
No eGFR < 20
No malignancy (except non-melanoma skin, cervical in-situ, breast ductal in situ, or stage 1 prostate carcinoma) in the last 10 yrs