Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 45 - 80 |
Updated: | 4/21/2016 |
Start Date: | October 2007 |
End Date: | August 2009 |
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).
safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).
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
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