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Completed

NCT Number: NCT00548587

Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With 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).

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brompton Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or Females, 45 - 80 years of age
  • 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
  • Randomisation possible within 24 hours of the onset of the most recent symptomatic episode.

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, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion
  • Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery
  • Clinically significant haematological, 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

Treatment and study plan

E5555

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability

    Time frame: Up to 16 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2007
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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