Acute Coronary Syndrome
Conditions
Keywords
Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
Brief summary
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
Interventions
DRUGE5555
E5555, 50 mg (tablet), taken orally, once a day.
DRUGPlacebo
Placebo tablet taken orally, once a day.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. | 3 months |
Countries
Japan
Outcome results
None listed