Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Florida Research Network
- Great Lakes Heart Center of Alpena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Placebo Comparator
E5555 50 mg
E5555 100 mg
E5555 200 mg
Placebo
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.