The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.

This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).

INCLUSION CRITERIA:

1. Males or Females, 45 - 80 years of age

2. Confirmed coronary artery disease defined as one of the following:

   • Post-acute coronary syndrome or myocardial infarction or
   • Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or
   • Angiographically documented lesion occluding ≥70% of a coronary vessel

   And at high risk as defined as one or more of the following:

   • Elevated hsCRP (high-sensitivity C-reactive protein)
   • Diabetes mellitus
   • History of carotid artery disease and/or peripheral artery disease
   • Thrombo-embolic transient ischemic attack or stroke >1 year prior to screening

3. All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.

EXCLUSION CRITERIA

1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
2. History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion
3. Clinically significant hematological, hepatic or renal abnormalities
4. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
5. Recent significant (as determined by the investigator) cardiovascular events