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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).