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