Case Study
Cardiovascular Outcome Trials
CARDIOVASCULAR OUTCOME TRIALS INTERNATIONAL: +44 (0) 20 7121 6161 | AMERICAS: +1 610 964 2000 | WORLDWIDE.COM CASE STUDY DESCRIPTION • Evaluating efficacy and safety of study drug added to standard therapy in reducing incidence of atherothrombotic events • A Phase III, randomized, double-blind, placebo- controlled study of a platelet PAR-1 receptor inhibitor in atherosclerosis (2007–2012) • Patients: Adults with a history of MI, ischemic stroke, or PAD • 26,499 randomized to 2 treatment arms CHALLENGE • To evaluate the efficacy and safety of the study drug when added to standard therapy, in reducing incidence of atherothrombotic events relative to the study therapy alone • Numerous cultures and time zones to navigate: 1,032 sites in 32 countries, including Asia-Pa