The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects "SPIRE-1"

Terminated

Phase 3 Results N/A

Trial Description

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence 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 >/= 70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg /dL (2.6 mmol/L).

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.

Trial Stopped: See Detailed Description

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Placebo
  • PF-04950615 Drug
    Other Names: RN316
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: PF-04950615
  • Bococizumab (PF-04950615) Drug
    Other Names: RN316
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: bococizumab (PF-04950615)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular event The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60 No
Secondary Hospitalization for unstable angina needing urgent revascularization The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60 No
Secondary A composite endpoint of CV death, non-fatal MI, and non-fatal stroke 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 No
Secondary A composite endpoint of all-cause death, non- fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization 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 No
Secondary A composite endpoint of all-cause death, non- fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization 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 No
Primary 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. 60 Months No
Secondary 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. 60 Months No
Secondary 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. 60 Months No
Secondary 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. 60 Months No
Secondary Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization. 60 Months No
Secondary 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. 60 Months No
Secondary Changes in levels of circulating biomarkers (lipids and hs-CRP) 60 Months No

Sponsors