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

Acute Coronary Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548587
• Other study ID #: E5555-G000-202
• Secondary ID: 2006-000296-15
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2007
• Last updated: January 5, 2016
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: November 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• E5555

• Placebo

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London
United States	Beloit Clinic, SC	Beloit	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Up to 16 weeks	Yes
Secondary	Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes		Up to 16 weeks	Yes