Cardiovascular Atlas
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FOURIER (evolocumab in people with cardiovascular disease)

A large trial of 27,564 people with atherosclerotic cardiovascular disease and raised LDL cholesterol who already took a statin. Half also received evolocumab, an injected PCSK9 antibody, and half received placebo. Evolocumab lowered LDL cholesterol and reduced heart and blood-vessel events over a median of 2.2 years.

Also called FOURIER · Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

  • Study
  • In this atlas

Overview

Design
Allocation: randomized. Intervention model: parallel. Masking: quadruple. Primary purpose: treatment. (Registry values, in lower case.)
Phase
Phase 3
Enrolled
  • 27,564 participants (enrolled count) (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT01764633
Started
(actual) (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Primary completion
(actual) (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Completion
(actual) (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Results first posted
(actual) (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, Hong Kong SAR China, Türkiye (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Phase 3, randomized, double-blind, placebo-controlled trial (NCT01764633), 27,564 participants enrolled, started 2013-02-08 and primary completion 2016-11-11. The abstract reports the primary composite in 9.8% against 11.3% (hazard ratio 0.85, 95% CI 0.79 to 0.92). The paper says it was funded by Amgen, the registry lead sponsor. The registry lists dyslipidemia as the condition.

Arms

  • Placebo

    Intervention None named

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

  • Evolocumab

    Intervention None named

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

Findings

No findings are published for this study.

Record details

Record id
cardio:fourier
Content hash
c273aa3c84f9099a9fa1bed07d5ec2b15be43ed9ca676000408432c37741c3f1