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Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina (UA) in high-risk vascular disease (HRVD) patients. The secondary objectives of the study are to test the hypotheses that evacetrapib 130 mg daily, in HRVD patients compared to placebo: * Increases high-density lipoprotein-cholesterol (HDL-C) at 3 months after randomization * Decreases low-density lipoprotein-cholesterol (LDL-C) at 3 months after randomization Reduces the incidence of the following: * Composite endpoint of CV death, MI, or stroke * A composite endpoint of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for UA * Composite endpoint of CV death, MI, or coronary revascularization * Composite endpoint of CV death, MI, stroke, or hospitalization for UA * Recurrence of any component of the primary composite endpoint among those who had already reached the primary endpoint * Coronary revascularization * MI * CV death * All-cause mortality * Hospitalization for UA * Stroke The tertiary objectives of the study are to test the hypotheses that evacetrapib 130 mg daily in HRVD patients compared to placebo improves lipid profile at 3 months after randomization as measured by: * Blood lipids (triglycerides [TG]), lipoproteins (non-HDL-C, very-low-density lipoproteins [VLDL-C]), apolipoproteins (Apo A-I, Apo A-II, Apo C-II, Apo C-III, Apo E, Apo B) * Lipoprotein(a) Reduces the incidence of the following: * Non-elective revascularization * Elective revascularization Exploratory objectives include: * To explore the relationship between levels of lipids and the incidence of the primary endpoint * To evaluate the effects of evacetrapib on exploratory biomarkers associated with the risk of I1V-MC-EIAN(c) Clinical Protocol Page 4 LY2484595 atherosclerosis, or glucose metabolism * To characterize the pharmacokinetics (PK) of evacetrapib, explore potential factors that may influence the PK, and explore the association of PK with efficacy, biomarkers, and safety parameters Other objectives will be outlined in the statistical analysis plan (SAP). Health Economics objectives include: * To compare evacetrapib to placebo with respect to major health care resource use, cumulative medical costs, and incremental cost effectiveness

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary revascularization, or hospitalization for unstable angina (UA) in high-risk vascular disease (HRVD) patients. The secondary objectives of the study are to test the hypotheses that evacetrapib 130 mg daily, in HRVD patients compared to placebo: * Increases high-density lipoprotein-cholesterol (HDL-C) at 3 months after randomization * Decreases low-density lipoprotein-cholesterol (LDL-C) at 3 months after randomization Reduces the incidence of the following: * Composite endpoint of CV death, MI, or stroke * A composite endpoint of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for UA * Composite endpoint of CV death, MI, or coronary revascularization * Composite endpoint of CV death, MI, stroke, or hospitalization for UA * Recurrence of any component of the primary composite endpoint among those who had already reached the primary endpoint * Coronary revascularization * MI * CV death * All-cause mortality * Hospitalization for UA * Stroke The tertiary objectives of the study are to test the hypotheses that evacetrapib 130 mg daily in HRVD patients compared to placebo improves lipid profile at 3 months after randomization as measured by: * Blood lipids (triglycerides [TG]), lipoproteins (non-HDL-C, very-low-density lipoproteins [VLDL-C]), apolipoproteins (Apo A-I, Apo A-II, Apo C-II, Apo C-III, Apo E, Apo B) * Lipoprotein(a) Reduces the incidence of the following: * Non-elective revascularization * Elective revascularization Exploratory objectives include: * To explore the relationship between levels of lipids and the incidence of the primary endpoint * To evaluate the effects of evacetrapib on exploratory biomarkers associated with the risk of I1V-MC-EIAN(c) Clinical Protocol Page 4 LY2484595 atherosclerosis, or glucose metabolism * To characterize the pharmacokinetics (PK) of evacetrapib, explore potential factors that may influence the PK, and explore the association of PK with efficacy, biomarkers, and safety parameters Other objectives will be outlined in the statistical analysis plan (SAP). Health Economics objectives include: * To compare evacetrapib to placebo with respect to major health care resource use, cumulative medical costs, and incremental cost effectiveness