A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome
NCT ID: NCT00830960
Last Updated: 2011-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
720 participants
INTERVENTIONAL
2009-02-28
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Prasugrel 60/10 Primary
Loading dose 60 mg followed by maintenance dose 10 mg/day
Prasugrel
Oral, daily, 90 days
Prasugrel 30/7.5 Primary
Loading dose 30 mg followed by maintenance dose 7.5 mg/day
Prasugrel
Oral, daily, 90 days
Prasugrel 30/5 Primary
Loading dose 30 mg followed by maintenance dose 5 mg/day
Prasugrel
Oral, daily, 90 days
Clopidogrel 300/75 Primary
Loading dose 300 mg followed by maintenance dose 75 mg/day
Clopidogrel
Oral, daily, 90 days
Prasugrel 30/5 Low Weight/Elderly
Loading dose 30 mg followed by maintenance dose 5 mg/day
Prasugrel
Oral, daily, 90 days
Clopidogrel 300/75 Low Weight/Elderly
Loading dose 300 mg followed by maintenance dose 75 mg/day
Clopidogrel
Oral, daily, 90 days
Interventions
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Prasugrel
Oral, daily, 90 days
Clopidogrel
Oral, daily, 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A person who is of East or Southeast Asian descent
* A person who is of the legal age of 18 (or age 21 in Singapore) and is mentally competent to provide a signed written informed consent before entering the study
* If a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control
Exclusion Criteria
* A person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study)
* A person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (TIA)
* A person who needs to take other antiplatelet therapy other than Aspirin for the duration of the study
* A person who receives daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued
* A person who has a severe liver disease, such as cirrhosis
* A person who has a condition such as alcoholism, mental illness, or drug dependence
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, , China
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Guangzhou, , China
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Hangzhou, , China
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Nanjing, , China
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Shanghai, , China
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Shenyang, , China
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Wenzhou, , China
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Xi'an, , China
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Daegu, , South Korea
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Kwangju, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
Countries
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Other Identifiers
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H7T-MC-TACE
Identifier Type: OTHER
Identifier Source: secondary_id
11299
Identifier Type: -
Identifier Source: org_study_id