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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01764633
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia Biological: Evolocumab Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : February 8, 2013
Primary Completion Date : November 11, 2016
Study Completion Date : November 11, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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: Evolocumab
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Other Names:
  • AMG 145
  • Repatha


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first [ Time Frame: 5 Years ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

  2. Time to cardiovascular death [ Time Frame: 5 years ]
    Time to cardiovascular death

  3. Time to death by any cause [ Time Frame: 5 years ]
    Time to death by any cause

  4. Time to first myocardial infarction [ Time Frame: 5 years ]
    Time to first myocardial infarction

  5. Time to first stroke [ Time Frame: 5 years ]
    Time to first stroke

  6. Time to first coronary revascularization [ Time Frame: 5 years ]
    Time to first coronary revascularization

  7. Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first [ Time Frame: 5 years ]
    Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first

  8. Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first [ Time Frame: 5 years ]
    Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764633


  Show 1287 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01764633     History of Changes
Other Study ID Numbers: 20110118
2014/01/004324 ( Registry Identifier: Clinical Trials Registry- India (CTRI) )
2012-001398-97 ( EudraCT Number )
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Amgen:
High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases