A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

Phase 2

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Placebo; Drug: E5555

• Registration Number: NCT00619164
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-20
• Primary Completion: 2009-09
• Status Verified: 2010-02
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. 45 - 80 years old (at time of informed consent)
2. Male or female (females of childbearing potential must be contracepted)
3. Confirmed acute coronary syndrome

Exclusion Criteria

1. Unwilling or unable to provide informed consent
2. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
3. Recent trauma or major surgery
4. Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
5. History of intracranial bleeding or history of hemorrhagic retinopathy
6. History of New York Heart Association (NYHA) class III or IV congestive heart failure
7. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Placebo	-
2	E5555	-
1	E5555	-
3	E5555	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.	3 months

Secondary Outcome Measures

Name	Time	Method
Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.	3 months