Clinical trial NCT00619164: A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Official title: A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Platelet Aggregation Inhibitors
Coronary Stenosis
Coronary Thrombosis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
timeFrame: 3 months
Secondary outcomes:
measure: Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.
timeFrame: 3 months
Other outcomes:
Locations:
city: Toyoake
country: Japan
state: Aichi
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyusyu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Ogaki
country: Japan
state: Gifu
city: Fukuyama
country: Japan
state: Hiroshima
city: Higashi-Hiroshima
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Himaji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Yokohama
country: Japan
state: Kanagawa
city: Omura
country: Japan
state: Nakasaki
city: Beppu
country: Japan
state: Oita
city: Urazoe
country: Japan
state: Okinawa
city: Wako
country: Japan
state: Saitama
city: Komatsushima
country: Japan
state: Tokushima
city: Bunkyo
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Hachioji
country: Japan
state: Tokyo
city: Itabashi
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Nerima
country: Japan
state: Tokyo
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Tanabe
country: Japan
state: Wakayama
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: New Product Development, Clinical Research Center, Eisai Co., Ltd.
name: Masaru Takeuchi
role: STUDY_DIRECTOR
References: