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

December 1, 2016 updated by: Eisai Inc.

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • Florida Research Network
    • Michigan
      • Alpena, Michigan, United States, 49707
        • Great Lakes Heart Center Of Alpena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E5555 50 mg
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
Experimental: E5555 100 mg
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
Active Comparator: E5555 200 mg
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets
Drug: Placebo
50 mg and/or 100 mg placebo tablets
Placebo Comparator: Placebo
Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: Placebo
50 mg and/or 100 mg placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability - especially the risk of bleeding
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: John Riefler, MD, Eisai Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E5555-G000-201
  • 2005-006029-94 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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