A Randomized, Double-Blind, Placebo-Controlled study to determine the safety and tolerability of E5555, and its Effects on Markers of Inflammation in Subjects with Coronary Artery Disease

E5555 is a small molecule that inhibits activation of PAR-1, the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for CAD and not a replacement for any currently established forms of treatment for CAD. This study will look at the safety and tolerability of E5555 in CAD patients for a period of 24 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be up to 31 weeks, to allow for a maximum 3 weeks screening period. The patient would be asked to attend clinic for a total of 11 visits over the course of the study, with visits being between 1 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, ECGs (up to 11 in total); blood tests (up to 11 in total) and regular intake of study medication (three tablets taken once a day with breakfast). Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail 3 additional visits and several additional blood samples being taken for pharmacokinetic and pharmacodynamic purposes.