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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No