Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)

Inclusion Criteria:

• Is within the age limits and has signed informed consent
• Weighs at least 50 kg
• Had a previous diagnosis of ACS (UA, STEMI, or NSTEMI), underwent PCI, and receivedone of the following treatments:
• Clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-8 weeks following clopidogrelloading dose (LD) of 300 mg or 600 mg at the time of PCI
• Ticagrelor MD of 90 mg twice daily (BID) and aspirin 81-100 mg for 1-4 weeks andswitching to clopidogrel MD of 75 mg and aspirin 81-100 mg for 2-4 weeksfollowing ticagrelor LD of 180 mg at the time of PCI
• Clopidogrel MD 75 mg and aspirin 81-100 mg for 2-8 weeks following ticagrelor LDof 180 mg at the time of PCI
• Or based on investigator's judgment with at least 2 weeks continued use ofclopidogrel MD and aspirin 81-100 mg per day before switching to prasugrel andmaximum 8 weeks P2Y12 inhibitors MD treatment (prasugrel is not allowed)
• Is willing and able to abide by the rules of the research unit and study restrictions
• If a woman of child-bearing potential, has a negative serum pregnancy test atscreening
• Agrees to use at least one method of contraception during the study

Exclusion Criteria:

• Has active bleeding, significant risk of hemorrhage, or unusual susceptibility tobleed
• Had previous hemorrhagic stroke at any time, or transient ischemic attack (TIA) orischemic stroke within 3 months before the informed consent date
• Has known allergies or hypersensitivity to prasugrel, aspirin, or any of theirexcipients
• Has significant hypertension at screening or baseline assessment
• Has hemoglobin levels <10.5 g/dL or hematocrit levels <30%
• Has severe left ventricular systolic dysfunction, ejection fraction <30%
• Is currently undergoing hemodialysis
• Has evidence of severe hepatic disease or any of the following: serum alaninetransaminase or aspartate transaminase ≥3 times the upper limit of normal (ULN); orbilirubin ≥2 times the ULN at screening
• Has any clinical laboratory result performed at screening that is determined to bedetrimental to the patient or could compromise the study as determined theInvestigator
• Has previously participated in this study or in another interventional trial that isnot compatible with this study
• Has evidence of significant active neuropsychiatric disease, alcohol abuse or drugabuse as determined by the Investigator