Status:
COMPLETED
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Coronary Arteriosclerosis
Acute Coronary Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or ar...
Eligibility Criteria
Inclusion
- A person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention.
- A person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent.
- If a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.
Exclusion
- A person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past.
- A person who has active internal bleeding or has a history of a bleeding disorder.
- Individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding.
- A person who has liver disease; for example, cirrhosis.
- A person who has a condition such as alcoholism, mental illness, or is drug dependent.
- A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class IV).
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
13619 Patients enrolled
Trial Details
Trial ID
NCT00097591
Start Date
November 1 2004
End Date
July 1 2007
Last Update
September 16 2010
Active Locations (1)
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1
For more information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Global Quintiles Study Line (1-866-615-4672) or speak with your physician
Indianapolis, Indiana, United States