Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

January 5, 2016 updated by: Eisai Inc.

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Clinical Events and Biomarkers in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome

This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

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

      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
    • Wisconsin
      • Beloit, Wisconsin, United States, 53511-2230
        • Beloit Clinic, SC

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. Presenting with features of non-ST segment elevation ACS (unstable angina or Myocardial infarction without persistent ST elevation). and at least one of the following two criteria on admission: Cardiac enzymes≥ ULN for the local institution OR ECG changes compatible with ischemia
  3. Randomisation possible within 24 hours of the onset of the most recent symptomatic episode.

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, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion
  3. Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery
  4. Clinically significant haematological, hepatic or renal abnormalities
  5. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
  6. 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.
Active Comparator: 2
Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.
Active Comparator: 3
Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.
Placebo Comparator: 4
Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: Up to 16 weeks
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes
Time Frame: Up to 16 weeks
Up to 16 weeks

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Rafal Ziecina, 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.

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

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • E5555-G000-202
  • 2006-000296-15 (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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