Clinical trial NCT00548587: Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Beloit
country: United States
facility: Beloit Clinic, SC
state: Wisconsin
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Eisai Limited
name: Rafal Ziecina, MD
role: STUDY_DIRECTOR
References:
citation: O'Donoghue ML, Bhatt DL, Wiviott SD, Goodman SG, Fitzgerald DJ, Angiolillo DJ, Goto S, Montalescot G, Zeymer U, Aylward PE, Guetta V, Dudek D, Ziecina R, Contant CF, Flather MD; LANCELOT-ACS Investigators. Safety and tolerability of atopaxar in the treatment of patients with acute coronary syndromes: the lessons from antagonizing the cellular effects of Thrombin-Acute Coronary Syndromes Trial. Circulation. 2011 May 3;123(17):1843-53. doi: 10.1161/CIRCULATIONAHA.110.000786. Epub 2011 Apr 18.