Serum fasting LDL cholesterol measurement
Item
fasting ldl-c ≥200 mg/dl (5.1 mmol/l) at screening and the presence of at least 1 of the following criteria:
boolean
C0582830 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction (mi)
boolean
C0027051 (UMLS CUI [1])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Coronary Artery Disease Angiography | Coronary Artery Disease Imaging Technique
Item
coronary artery disease documented by angiography or any other accepted imaging technique
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
Exercise test Positive | ST segment depression Exercise Maximal | Myocardial perfusion defect Localized study using thallium with tomography | Myocardial perfusion defect Single-Photon Emission-Computed Tomography
Item
positive exercise test (≥1 mm st-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography)
boolean
C0015260 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0520887 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0205289 (UMLS CUI [2,3])
C0428858 (UMLS CUI [3,1])
C0846135 (UMLS CUI [3,2])
C0428858 (UMLS CUI [4,1])
C0040399 (UMLS CUI [4,2])
Atherosclerosis | Peripheral Arterial Disease | Symptomatic Carotid Artery Disease | Aortic Aneurysm, Abdominal
Item
other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
boolean
C0004153 (UMLS CUI [1])
C1704436 (UMLS CUI [2])
C0007273 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0162871 (UMLS CUI [4])
Serum fasting LDL cholesterol measurement
Item
or, if alternative above were not met, fasting ldl-c ≥300 mg/dl (7.8 mmol/l)
boolean
C0582830 (UMLS CUI [1])
Statin therapy Maximum Tolerated Dose Stable
Item
on stable, maximally tolerated statin therapy for 8 weeks
boolean
C1278454 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Hypolipidemic Agents Additional Stable
Item
on stable, medication from an additional class of hypolipidemic agents for 8 weeks.
boolean
C0086440 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Fat-Restricted Diet Stable
Item
on stable, low fat diet for 12 weeks
boolean
C0242970 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Stable body weight
Item
stable weight for 6 weeks
boolean
C0517386 (UMLS CUI [1])
Medical Problem | Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Angina, Unstable | Heart failure | Cardiac Arrhythmia | Hypertensive disease | Hematological Disease | Liver disease | Malignant Neoplasms | Digestive System Disorders | Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
Item
significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, type i diabetes, or uncontrolled type ii diabetes
boolean
C1254481 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0018801 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0020538 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0023895 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0012242 (UMLS CUI [12])
C0011854 (UMLS CUI [13])
C0743118 (UMLS CUI [14])
Apheresis | Apheresis Expected
Item
apheresis within 3 months prior to screening or expected to start apheresis during the treatment phase
boolean
C0005791 (UMLS CUI [1])
C0005791 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])