Overview

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

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Collaborator:
Daiichi Sankyo Co., Ltd.
Treatments:
Clopidogrel
Prasugrel Hydrochloride
Ticlopidine
Criteria
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