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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)

This study has been terminated.
(See Detailed Description)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01975389
First Posted: November 4, 2013
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).

Condition Intervention Phase
Cardiovascular Disease Drug: bococizumab (PF-04950615) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint is the time from randomization to the first occurrence of a major cardiovascular (CV) event, a composite endpoint of CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: 60 Months ]
    Confirmed occurrence of a major CV event: a composite endpoint which includes CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization


Secondary Outcome Measures:
  • Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke. [ Time Frame: 60 Months ]
    Confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke

  • Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: 60 Months ]
    Confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization

  • Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke. [ Time Frame: 60 Months ]
    Confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke

  • Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization [ Time Frame: 60 Months ]
    Confirmed occurrence of hospitalization for unstable angina needing urgent revascularization

  • Time to first occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina; and each component of every composite endpoint, and an endpoint of hospitalization for congestive heart failure. [ Time Frame: 60 months ]
    Confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina; and each component of every composite endpoint, and an endpoint of hospitalization for congestive heart failure

  • Changes in levels of circulating biomarkers (lipids and hs-CRP) [ Time Frame: 60 Months ]
    Changes in levels of circulating biomarkers (lipids and hs-CRP)


Enrollment: 10564
Actual Study Start Date: October 2013
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bococizumab (PF-04950615)
150 mg, every 2 weeks, subcutaneous.
Drug: bococizumab (PF-04950615)
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Other Name: RN316
Placebo Comparator: Placebo
Placebo comparator, every 2 weeks, subcutaneous.
Drug: Placebo
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

Detailed Description:
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. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be on background lipid lowering treatment.
  • Must be at high risk of a CV event.
  • Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

Exclusion Criteria:

  • Planned coronary (PCI or CABG) or other arterial revascularization.
  • New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
  • Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
  • History of hemorrhagic stroke.
  • Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975389


  Show 1596 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Pfizer:
myocardial infarction
stroke
hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases