Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.

Criteria

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