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.
- 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.
- 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
- A person who has cardiogenic shock, a refractory ventricular arrhythmia, or
congestive heart failure (class IV).