Background: SPIRE (Studies of PCSK9 Inhibition and the Reduction of vascular Events) is an extensive research program to study bococizumab, an investigational PCSK9i. The SPIRE Phase 3 global clinical development program involves two cardiovascular outcomes studies (SPIRE-1 and SPIRE-2) investigating the ability of bococizumab to reduce cardiovascular disease in a broad range of high-risk primary and secondary prevention patients. In these multicenter, double-blind outcomes studies, patients with LDL-C ≥ 1.81 to < 2.59 mmol/L or non-HDL-C ≥ 2.59 to < 3.36 mmol/L (SPIRE-1) respectively patients with LDL-C ≥ 2.59 mmol/L or non-HDL-C ≥ 3.36 mmol/L (SPIRE-2) are randomized to receive either bococizumab 150mg or placebo every two weeks in addition to highly-effective statins unless patients have documented statin intolerance. Trial Registration No: SPIRE-1: NCT01975376 ( Link SPIRE-2: NCT01975389 ( Link Trial Status: SPIRE-1: terminated SPIRE-2: terminated Enrolling Centers: Worldwide: multicentric Core Study Team:
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