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

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ClinicalTrials.gov Identifier: NCT01764633
Recruitment Status : Completed
First Posted : January 9, 2013
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Biological: Evolocumab
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 1242 clinical centers in 49 countries in the regions of Europe (62.9%), North America (16.6%), Asia Pacific (13.9%), and Latin America (6.6%) from 08 February 2013 to 05 June 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants were randomized in a 1:1 ratio to receive either subcutaneous (SC) evolocumab or placebo. Randomization was stratified by the final screening low-density lipoprotein cholesterol (LDL-C) level (< 85 mg/dL vs ≥ 85 mg/dL) and by geographical region.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
Evolocumab Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.

Participant Flow:   Overall Study
    Placebo   Evolocumab
STARTED   13780   13784 
Received Treatment   13756   13769 
COMPLETED   13662   13691 
NOT COMPLETED   118   93 
Withdrawal by Subject                105                88 
Lost to Follow-up                13                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference.
Evolocumab Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference.
Total Total of all reporting groups

Baseline Measures
   Placebo   Evolocumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 13780   13784   27564 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (8.9)   62.5  (9.1)   62.5  (9.0) 
Age, Customized 
[Units: Participants]
Count of Participants
     
< 65 years      7687  55.8%      7623  55.3%      15310  55.5% 
≥ 65 years      6093  44.2%      6161  44.7%      12254  44.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3382  24.5%      3387  24.6%      6769  24.6% 
Male      10398  75.5%      10397  75.4%      20795  75.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1084   7.9%      1093   7.9%      2177   7.9% 
Not Hispanic or Latino      12694  92.1%      12688  92.0%      25382  92.1% 
Unknown or Not Reported      2   0.0%      3   0.0%      5   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      80   0.6%      60   0.4%      140   0.5% 
Asian      1349   9.8%      1374  10.0%      2723   9.9% 
Black or African American      352   2.6%      317   2.3%      669   2.4% 
Native Hawaiian or Other Pacific Islander      11   0.1%      15   0.1%      26   0.1% 
White      11710  85.0%      11748  85.2%      23458  85.1% 
Multiple      12   0.1%      19   0.1%      31   0.1% 
Other      266   1.9%      251   1.8%      517   1.9% 
Low-density Lipoprotein Cholesterol 
[Units: Participants]
Count of Participants
     
< 85 mg/dL      4803  34.9%      4809  34.9%      9612  34.9% 
≥ 85 mg/dL      8977  65.1%      8975  65.1%      17952  65.1% 
Geographical Region 
[Units: Participants]
Count of Participants
     
Europe      8669  62.9%      8667  62.9%      17336  62.9% 
North America      2284  16.6%      2286  16.6%      4570  16.6% 
Latin America      910   6.6%      913   6.6%      1823   6.6% 
Asia Pacific      1917  13.9%      1918  13.9%      3835  13.9% 


  Outcome Measures

1.  Primary:   Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

2.  Secondary:   Time to Cardiovascular Death, Myocardial Infarction, or Stroke   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

3.  Secondary:   Time to Cardiovascular Death   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

4.  Secondary:   Time to All Cause Death   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

5.  Secondary:   Time to First Myocardial Infarction   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

6.  Secondary:   Time to First Stroke   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

7.  Secondary:   Time to First Coronary Revascularization   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

8.  Secondary:   Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]

9.  Secondary:   Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack   [ Time Frame: Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


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 Submitted: January 8, 2013
First Posted: January 9, 2013
Results First Submitted: December 15, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018