Clinical Trial Summary : 20110118
Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk  (FOURIER) FDA Regulated: Yes

This study has been completed.
Verified by Amgen, November 2017

Sponsored by: Amgen
Information provided by: Amgen

Purpose

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.


Condition Intervention Phase
Dyslipidemia
Biological/Vaccine: Evolocumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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


Further study details as provided by Amgen

Primary Outcome Measures:
  • The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first.

Secondary Outcome Measures:
  • Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

  • Time to cardiovascular death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death

  • Time to death by any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to death by any cause

  • Time to first myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first myocardial infarction

  • Time to first stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first stroke

  • Time to first coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first coronary revascularization

  • Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first

  • Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first

Enrollment: 27564
Study Start Date:2013 February DDDD Study Start Date Type: Actual

Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
Drug: Placebo
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Experimental: Evolocumab
Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference.
Biological/Vaccine: Evolocumab
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Other Name: AMG 145
Other Name: Repatha


Eligibility

Ages Eligible for Study:  40 Years  to 85 Years
Genders Eligible for Study:  Both
Gender Based: 
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

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


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

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