A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention

Completed · Phase 3

Conditions studied: Coronary Arteriosclerosis, Acute Coronary Syndromes

In brief

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 are expected to need, a percutaneous coronary intervention (PCI; also called a balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.

Key facts

Study ID

NCT00097591

Run by

Eli Lilly and Company

People needed

13619

Starts

2004-11-01

Expected to finish

2007-07-01

Last updated by the study team

2010-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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