FOURIER - Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk

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Updated on 25 March 2021


FOURIER - Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk


A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy in Patients with Clinically Evident Cardiovascular Disease.

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.

Condition Dyslipidemia
Clinical Study IdentifierTX139105
Last Modified on25 March 2021


Yes No Not Sure

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 LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
NYHA class III or IV, or last know left ventricular ejection fraction <30%
Uncontrolled hypertension
Uncontrolled or recurrent ventricular tachycardia
Untreated hyperthyroidism or hypothyroidism
Homozygous familial hypercholesterolemia
LDL or plasma apheresis
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