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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00548587
• Collaborator: (none)
• Enrollment: 600
• Locations: 2
• Arms: 4
• Duration (Months): 22
• Patients Per Site: 300
• Patients Per Site Per Month: 13.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: E5555; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.	Drug: E5555; Drug: Placebo
Active Comparator: 2 Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.	Drug: E5555; Drug: Placebo
Active Comparator: 3 Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.	Drug: E5555; Drug: Placebo
Placebo Comparator: 4 Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [Up to 16 weeks]

Secondary Outcome Measures

1. Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes [Up to 16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beloit Clinic, SC	Beloit	Wisconsin	United States	53511-2230
2	Royal Brompton Hospital	London		United Kingdom	SW3 6NP

Sponsors and Collaborators

• Eisai Inc.

Investigators

• Study Director: Rafal Ziecina, MD, Eisai Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT00548587
• Other Study ID Numbers: E5555-G000-202; 2006-000296-15
• First Posted: Oct 24, 2007
• Last Update Posted: Feb 4, 2016
• Last Verified: Nov 1, 2015

• Keywords provided by Eisai Inc.: Acute Coronary Syndrome
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Feb 4, 2016