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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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

Key facts

Study ID

NCT00312052

Run by

Eisai Inc.

People needed

720

Starts

2007-09-01

Expected to finish

2009-08-01

Last updated by the study team

2016-12-05

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Florida Research Network — Gainesville, Florida, United States
• Great Lakes Heart Center of Alpena — Alpena, Michigan, United States

Full record on ClinicalTrials.gov

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