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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01764633
First received: January 8, 2013
Last updated: September 17, 2014
Last verified: September 2014

January 8, 2013
September 17, 2014
January 2013
December 2017   (final data collection date for primary outcome measure)
Time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization [ 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.
Same as current
Complete list of historical versions of study NCT01764633 on ClinicalTrials.gov Archive Site
  • Time to cardiovascular death, myocardial infarction, or stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first
  • Time to death by any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to death by any cause
  • Time to cardiovascular death or hospitalization for worsening heart failure [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
22500
February 2018
December 2017   (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
Both
40 Years to 85 Years
No
Contact: Amgen Call Center 866-572-6436
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   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
 
NCT01764633
20110118, 2014/01/004324
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
September 2014

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