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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Cardiovascular Disease

Treatments: Drug: Placebo; Drug: bococizumab (PF-04950615)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975376

CV OUTCOMES 1

B1481022

2013-002646-36 (EudraCT Number)

CV OUTCOMES 2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 16,784 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be on background lipid lowering treatment.
• Must be at high risk of a CV event.
• Must have an LDL C >/=70 mg/dL (1.8 mmol/L) or non-HDL-C >/= 100 mg/dL (2.6 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16,784 participants in 2 patient groups, including a placebo group

bococizumab (PF-04950615)

Experimental group

Description:

150 mg, every 2 weeks, subcutaneous

Treatment:

Drug: bococizumab (PF-04950615)

Placebo

Placebo Comparator group

Description:

Placebo comparator, every 2 weeks, subcutaneous.

Treatment:

Drug: Placebo