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Status:

COMPLETED

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

Lead Sponsor:

Eisai Inc.

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

45-80 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

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 tr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2009

    Estimated Enrollment :

    720 Patients enrolled

    Trial Details

    Trial ID

    NCT00312052

    Start Date

    September 1 2007

    End Date

    August 1 2009

    Last Update

    December 5 2016

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Florida Research Network

    Gainesville, Florida, United States, 32605

    2

    Great Lakes Heart Center of Alpena

    Alpena, Michigan, United States, 49707