Table 2.
Major Exclusion Criteria
| History of hemorrhagic stroke |
|---|
| Personal or family history of hereditary muscular disorders |
| NYHA class III or IV HF, or last known LVEF <30% |
| Uncontrolled serious cardiac arrhythmia in the past 3 months prior to randomization |
| MI, UA, PCI, CABG, or stroke within 3 months prior to randomization |
| Planned cardiac surgery or revascularization |
| Type 1 DM, poorly controlled type 2 DM (HbA1c >8.5%), newly diagnosed type 2 DM within 6 months of randomization |
| Uncontrolled HTN defined as sitting SBP >160 mm Hg or DBP >100 mm Hg |
| Subject who has taken, in the last 4 weeks, red yeast rice, >200 mg/d niacin, or prescription lipid‐regulating drugs (eg, fibrates and derivatives, statins, or ezetimibe) other than bile‐acid sequestering resin or stanols and stanol esters |
| Patient who has taken a CETP inhibitor in the last 12 months prior to LDL‐C screening, such as anacetrapib, dalcetrapib, or evacetrapib |
| Treatment in the last 3 months prior to LDL‐C screening with any of the following drugs: systemic cyclosporine, systemic corticosteroids |
| Uncontrolled hypothyroidism or hyperthyroidism |
| eGFR <30 mL/min/1.73 m2 at screening |
| Active liver disease or hepatic dysfunction, defined as AST or ALT >3× ULN |
| Known active infection or major hematologic, renal, metabolic, GI, or endocrine dysfunction in the judgment of the investigator |
| Diagnosis of DVT or PE within 3 months prior to randomization |
| Unreliability as a study participant based on the investigator's (or designee's) knowledge of the patient (eg, alcohol or other drug) |
| Currently enrolled in another investigational device or drug study, or <30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s) |
| Female patient who has either (1) not used ≥1 highly effective method of contraception for ≥1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the patient is sterilized or postmenopausal |
| Patient who is pregnant or breastfeeding, or planning to become pregnant during treatment and/or within weeks after the end of treatment |
| Patient who has previously received evolocumab or any other investigational therapy to inhibit PCSK9 |
| Malignancy except nonmelanoma skin cancers, cervical carcinoma, or breast DCIS within the last 5 years |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CABG, coronary artery bypass grafting; CETP, cholesteryl ester transfer protein; DBP, diastolic blood pressure; DCIS, ductal carcinoma in situ; DM, diabetes mellitus; DVT, deep vein thrombosis; eGFR, estimated glomerular filtration rate; GI, gastrointestinal; HbA1c, glycated hemoglobin; HF, heart failure; HTN, hypertension; LDL‐C, low‐density lipoprotein cholesterol; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PCSK9, proprotein convertase subtilisin/kexin type 9; PE, pulmonary embolism; SBP, systolic blood pressure; UA, unstable angina; ULN, upper limit of normal.