A Comparison of Antiplatelet Therapies in Asian Subjects With Acute Coronary Syndrome

Lilly

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome

Treatments: Drug: Prasugrel; Drug: Clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830960

H7T-MC-TACE (Other Identifier)

11299 (Registry Identifier)

Details and patient eligibility

About

The study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of Asian participants with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention.

Enrollment: 720 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A person who has been diagnosed with acute coronary syndrome (ACS) and is to undergo a percutaneous coronary intervention (PCI)
• 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 has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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720 participants in 6 patient groups

Prasugrel 60/10 Primary

Experimental group

Description:

Loading dose 60 mg followed by maintenance dose 10 mg/day

Treatment:

Drug: Prasugrel

Prasugrel 30/7.5 Primary

Experimental group

Description:

Loading dose 30 mg followed by maintenance dose 7.5 mg/day

Treatment:

Drug: Prasugrel

Prasugrel 30/5 Primary

Experimental group

Description:

Loading dose 30 mg followed by maintenance dose 5 mg/day

Treatment:

Drug: Prasugrel

Clopidogrel 300/75 Primary

Active Comparator group

Description:

Loading dose 300 mg followed by maintenance dose 75 mg/day

Treatment:

Drug: Clopidogrel

Prasugrel 30/5 Low Weight/Elderly

Experimental group

Description:

Loading dose 30 mg followed by maintenance dose 5 mg/day

Treatment:

Drug: Prasugrel

Clopidogrel 300/75 Low Weight/Elderly

Active Comparator group

Description:

Loading dose 300 mg followed by maintenance dose 75 mg/day

Treatment:

Drug: Clopidogrel