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

Purpose

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).

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: E5555 Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Safety and tolerability [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: E5555 50 mg (one 50 mg active and two 100 mg placebo) tablets taken once daily for 12 weeks.
2: Active Comparator	Drug: E5555 100 mg (one 50 mg placebo; one 100 mg active and one 100 mg placebo) tablet taken once daily for 12 weeks.
3: Active Comparator	Drug: E5555 200 mg (one 50 mg placebo and two 100 mg active) tablets taken once daily for 12 weeks.
4: Placebo Comparator	Drug: Placebo One 50 mg placebo and two 100 mg placebo tablets taken once daily for 12 weeks.

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548587

Contacts


Contact: Eisai Medical Services	1-888-422-4743

Locations


United States, Wisconsin
	Beloit Clinic, SC	Recruiting
	Beloit, Wisconsin, United States, 53511-2230

United Kingdom
	Royal Brompton Hospital	Recruiting
	London, United Kingdom, SW3 6NP

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators


Study Director:	Rafal Ziecina, MD	Eisai Limited

More Information

Responsible Party:	Eisai Limited ( Rafal Ziecina, MD )
Study ID Numbers:	E5555-G000-202
First Received:	October 22, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00548587
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:

Acute Coronary Syndrome

Study placed in the following topic categories:

Heart Diseases

Myocardial Ischemia

Acute Coronary Syndrome

Vascular Diseases

Ischemia

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00548587