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

Eisai

Status and phase: Completed; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: E5555; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548587

E5555-G000-202

2006-000296-15 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 600 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Treatment:

Drug: E5555

Drug: Placebo

2

Active Comparator group

Description:

Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.

Treatment:

Drug: E5555

Drug: Placebo

3

Active Comparator group

Description:

Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.

Treatment:

Drug: E5555

Drug: Placebo

4

Placebo Comparator group

Description:

Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.

Treatment:

Drug: Placebo