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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01975389
First received: October 21, 2013
Last updated: July 26, 2016
Last verified: July 2016

October 21, 2013
July 26, 2016
October 2013
April 2017   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Cardiovascular event [ Time Frame: The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60 ] [ Designated as safety issue: No ]
Confirmed occurrence of a major cardiovascular event, a composite endpoint which includes CV death, non fatal MI, non fatal stroke, and hospitalization for unstable angina needing urgent revascularization
Complete list of historical versions of study NCT01975389 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in levels of circulating biomarkers (lipids and hs-CRP)
  • Hospitalization for unstable angina needing urgent revascularization [ Time Frame: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of CV death, non fatal MI, and non fatal stroke [ Time Frame: 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, assessed up to Month 60 ] [ Designated as safety issue: No ]
  • A composite endpoint of all-cause death, non fatal MI, and non fatal stroke, and hospitalization for unstable angina needing urgent revascularization. [ Time Frame: 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, and hospitalization for unstable angina needing urgent revascularization, assessed up to M60 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
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
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).
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: Prevention
Cardiovascular Disease
  • 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
  • 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.
  • Experimental: bococizumab (PF-04950615)
    150 mg, every 2 weeks, subcutaneous.
    Intervention: Drug: bococizumab (PF-04950615)
  • Placebo Comparator: Placebo
    Placebo comparator, every 2 weeks, subcutaneous.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11000
July 2017
April 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   India,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01975389
B1481038, CV OUTCOMES 2, 2013-002795-41
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

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