Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)

Amgen

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia

Treatments: Drug: Placebo; Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764633

20110118

2014/01/004324 (Registry Identifier)

2012-001398-97 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 27,564 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27,564 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.

Treatment:

Drug: Placebo

Evolocumab

Experimental group

Description:

Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.

Treatment:

Biological: Evolocumab