Inclusion Criteria
Subject must understand the aims, investigational procedures and possible consequences of the study).
boolean
Refer to Appendix 1: Highly Effective Methods For Avoidance Of Pregnancy In Women Of Childbearing Potential. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
boolean
statin therapy
boolean
Chronic CHD documented by at least one of the following: a. prior MI (>1 month prior to randomisation). b. prior coronary revascularization procedure [percutaneous coronary intervention (PCI) > 1 month prior to randomization or coronary artery bypass graft (CABG) >3 months prior to randomization]. c. multivessel CHD involving major epicardial coronary arteries confirmed by coronary angiography at any time (without revascularization).
boolean
At least one of the following additional predictors of CV risk [a through f]: a. age >60 years at randomization. b. diabetes mellitus requiring pharmacothearpy. c. HDL-C <40 mg/dL (1.03 mmol/L). d. smoker (defined as at least 5 cigarettes per day on average) or a previous smoker (defined as at least 5 cigarettes per day on average when smoking) who discontinued within the past 3 months. e. significant renal dysfunction (defined as estimated glomerular filtration rate [eGFR] >30 and <59 mL/min per 1.73 m2 OR urine ACR >30 mg albumin/g creatinine). f. polyvascular disease manifested as coexistent clinically diagnosed arterial disease in at least 2 arterial territories, defined as: > chronic CHD and cerebrovascular disease defined as carotid artery disease or prior ischemic stroke >3 months. OR > chronic CHD and peripheral arterial disease (PAD).
boolean
Exclusion Criteria
Planned coronary revascularization
boolean
Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence of abnormal liver function test [total bilirubin or alkaline phosphatase >1.5 x upper limit of normal (ULN); or ALT or AST >2.5 x ULN] or other hepatic abnormalities that in the opinion of the Investigator would preclude the subject from participation in the study.
boolean
renal impairment
boolean
heart failure
boolean
hypertension
boolean
(e.g., very severe chronic airways disease, known human immunodeficiency virus [HIV] positive, or cancer in the past five years other than non-melanoma skin cancer).
boolean
asthma
boolean
All female subjects of childbearing potential must have a urine ß?-human chorionic gonadotropin [hCG] pregnancy test performed at Screening and/or within 7 days prior to randomization.
boolean
Refer to Appendix 2: Clinical criteria for diagnosing anaphylaxis [Sampson, 2006]
boolean
Alcohol or drug abuse
boolean
intake CYP3A4 inhibitors
boolean
Lp-PLA2 activity
boolean
exposure to darapladib
boolean
Use of another investigational product
boolean
study of investigational device
boolean
other reason for exclusion
boolean