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The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2)

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ClinicalTrials.gov Identifier: NCT01975389
Recruitment Status : Terminated (See Detailed Description)
First Posted : November 4, 2013
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cardiovascular Disease
Interventions: Drug: bococizumab (PF-04950615)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents.

Reporting Groups
  Description
Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Bococizumab (PF-04950615) Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.

Participant Flow:   Overall Study
    Placebo   Bococizumab (PF-04950615)
STARTED   5283   5281 
Treated   5279   5276 
COMPLETED   5031   5045 
NOT COMPLETED   252   236 
Adverse Event                10                6 
Death                61                54 
Lost to Follow-up                81                86 
Withdrawal by Subject                90                76 
Other                6                9 
Randomized, not treated                4                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.
Full analysis set (FAS): all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab cardiovascular (CV) outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.

Reporting Groups
  Description
Placebo Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Bococizumab (PF-04950615) Participants received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Participants were followed up to 40 days after the last dose.
Total Total of all reporting groups

Baseline Measures
   Placebo   Bococizumab (PF-04950615)   Total 
Overall Participants Analyzed 
[Units: Participants]
 5283   5281   10564 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.5  (9.5)   62.2  (9.6)   62.4  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1849  35.0%      1792  33.9%      3641  34.5% 
Male      3434  65.0%      3489  66.1%      6923  65.5% 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      852  16.1%      892  16.9%      1744  16.5% 
Not Hispanic or Latino      4430  83.9%      4387  83.1%      8817  83.5% 
Unknown or Not Reported      1   0.0%      2   0.0%      3   0.0% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      118   2.2%      105   2.0%      223   2.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      246   4.7%      252   4.8%      498   4.7% 
White      4776  90.4%      4784  90.6%      9560  90.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      143   2.7%      140   2.7%      283   2.7% 


  Outcome Measures

1.  Primary:   Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years) ]

2.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years) ]

3.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years) ]

4.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years) ]

5.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years) ]

6.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years) ]

7.  Secondary:   Event Rate Per 100 Participant-years for Cardiovascular (CV) Death   [ Time Frame: From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years) ]

8.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years) ]

9.  Secondary:   Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)   [ Time Frame: From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years) ]

10.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years) ]

11.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years) ]

12.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years) ]

13.  Secondary:   Event Rate Per 100 Participant-years for Fatal Stroke   [ Time Frame: From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years) ]

14.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years) ]

15.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years) ]

16.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years) ]

17.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years) ]

18.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years) ]

19.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years) ]

20.  Secondary:   Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations   [ Time Frame: From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years) ]

21.  Secondary:   Event Rate Per 100 Participant-years for All-cause Death   [ Time Frame: From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years) ]

22.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14   [ Time Frame: Baseline, Week 14 ]

23.  Secondary:   Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14   [ Time Frame: Baseline, Week 14 ]

24.  Secondary:   Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement   [ Time Frame: Baseline, last post-baseline measurement (any time up to Week 140) ]

25.  Secondary:   Percent Change From Baseline in Lipid Levels at Week 14   [ Time Frame: Baseline, Week 14 ]

26.  Secondary:   Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14   [ Time Frame: Baseline, Week 14 ]

27.  Secondary:   Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14   [ Time Frame: Baseline, Week 14 ]


  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
As specified in statistical analysis plan, due to discontinuation of the bococizumab clinical development program, health care resource utilization endpoints were not evaluated.


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01975389     History of Changes
Other Study ID Numbers: B1481038
CV OUTCOMES 2
2013-002795-41 ( EudraCT Number )
First Submitted: October 21, 2013
First Posted: November 4, 2013
Results First Submitted: March 21, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018