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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01764633
First received: January 8, 2013
Last updated: December 27, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Dyslipidemia
Biological: Evolocumab (AMG 145)
Other: Placebo
Drug: Effective statin therapy
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

Resource links provided by NLM:


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 ]
    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 ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

  • Time to cardiovascular death [ Time Frame: 5 years ]
    Time to cardiovascular death

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

  • Time to first myocardial infarction [ Time Frame: 5 years ]
    Time to first myocardial infarction

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

  • Time to first coronary revascularization [ Time Frame: 5 years ]
    Time to first coronary revascularization

  • 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

  • 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


Enrollment: 27564
Study Start Date: February 2013
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Evolocumab (AMG 145) Q2W or QM plus effective statin dose
Biological: Evolocumab (AMG 145)
Evolocumab (AMG 145)
Drug: Effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin
Placebo Comparator: Arm 2
Placebo Q2W or QM plus effective statin dose
Other: Placebo
Placebo
Drug: Effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin

  Eligibility

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 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764633

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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01764633     History of Changes
Other Study ID Numbers: 20110118  2014/01/004324 
Study First Received: January 8, 2013
Last Updated: December 27, 2016

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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 20, 2017