Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eisai Co., Ltd.
Treatments:
Platelet Aggregation Inhibitors
Criteria
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