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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: June 19, 2017
Last verified: June 2017
January 8, 2013
June 19, 2017
February 2013
November 2016   (Final data collection date for primary outcome measure)
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.
Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization [ 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.
Complete list of historical versions of study NCT01764633 on ClinicalTrials.gov Archive Site
  • 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
  • Time to cardiovascular death, myocardial infarction, or stroke [ Time Frame: 5 years ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
  • Time to death by any cause [ Time Frame: 5 years ]
    Time to death by any cause
  • Time to cardiovascular death or hospitalization for worsening heart failure [ Time Frame: 5 years ]
    Time to cardiovascular death or hospitalization for worsening heart failure, whichever occurs first
  • Time to ischemic fatal or non-fatal stroke or TIA [ Time Frame: 5 years ]
    Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first
Not Provided
Not Provided
 
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
  • Biological: Evolocumab (AMG 145)
    Evolocumab (AMG 145)
  • Other: Placebo
    Placebo
  • Drug: Effective statin therapy
    Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin
  • Experimental: Arm 1
    Evolocumab (AMG 145) Q2W or QM plus effective statin dose
    Interventions:
    • Biological: Evolocumab (AMG 145)
    • Drug: Effective statin therapy
  • Placebo Comparator: Arm 2
    Placebo Q2W or QM plus effective statin dose
    Interventions:
    • Other: Placebo
    • Drug: Effective statin therapy
Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27564
November 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Iceland,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Czech Republic
 
NCT01764633
20110118
2014/01/004324 ( Registry Identifier: Clinical Trials Registry- India (CTRI) )
Yes
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP