Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Coronary Syndrome
In brief
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).
Key facts
- Study ID
- NCT00548587
- Run by
- Eisai Inc.
- People needed
- 600
- Starts
- 2007-10-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2016-02-04
Who can join
Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Beloit Clinic, SC — Beloit, Wisconsin, United States
- Royal Brompton Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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