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Completed

NCT Number: NCT00619164

A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Coronary Disease Coronary Stenosis Coronary Thrombosis Embolism and Thrombosis Heart Diseases Myocardial Ischemia Thrombosis Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toyoake, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 45 - 80 years old (at time of informed consent)
  • Male or female (females of childbearing potential must be contracepted)
  • Confirmed acute coronary syndrome

Exclusion criteria

  • Unwilling or unable to provide informed consent
  • History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
  • Recent trauma or major surgery
  • Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
  • History of intracranial bleeding or history of hemorrhagic retinopathy
  • History of New York Heart Association (NYHA) class III or IV congestive heart failure
  • Pregnant or lactating women

Treatment and study plan

E5555

Drug

E5555, 50 mg (tablet), taken orally, once a day.

Placebo

Drug

Placebo tablet taken orally, once a day.

Primary outcomes

  1. Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.

    Time frame: 3 months

Secondary outcomes

  1. Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
First posted
Feb 20, 2008
Registry last updated
May 13, 2013

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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