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


Phase 3 Results N/A

Eligibility Criteria

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.