Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation 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

• Males or Females, 45 - 80 years of age
• 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
• All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.

Exclusion criteria

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