Integrated Biomarker and Imaging Study-2 (IBIS-2):
IBIS-2 (Study 026) was a multi-center, randomized, double blind, placebo-controlled, parallel group study designed to examine the effects of once daily Darapladib Enteric Coated Tablet 160 mg (n = 172) on intermediate cardiovascular endpoints compared to placebo (n = 151) (38). The study evaluated intravascular ultrasound (IVUS)-based imaging parameters, circulating biomarkers, endothelial function, safety and tolerability over the 1-year treatment duration in subjects from 10 countries in Europe (Denmark, Netherlands, Germany, Switzerland, Poland, Austria, Spain, Norway, Belgium, Czech Republic). By design, the study included approximately 50% of subjects with acute coronary syndrome (ACS), either ST-elevation Myocardial Infarction (STEMI) or Non-STEMI, or non-ACS patients with coronary heart disease. The mean age of subjects was 58 years (range, 33 to 82 years), and the majority of participants were white (98%) and male (82%).