The Effect on Blood Cells, Known as Platelets, Using Prasugrel vs Clopidogrel in Patients With the Heart Problem Acute Coronary Syndrome (ACS)

A Randomized Double-Blind Cross-Over Study Comparing the Pharmacodynamic (PD)Response in Subjects With ACS Receiving 14 Days 10-mg Maintenance Dose (MD) Prasugrel vs 14 Days 150-mg MD Clopidogrel After Using a 900-mg Loading Dose (LD) of Clopidogrel to Reduce Ongoing Platelet Activation

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

Inclusion Criteria:

• Present with acute coronary syndrome (ACS) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose).
• Are between the ages of 18 and 85 years.
• Willing and able to sign informed consent.

Exclusion Criteria:

• Have overt ST-segment elevation myocardial infarction (STEMI).
• Have cardiogenic shock.
• Have refractory ventricular arrhythmias.
• Have New York Heart Association (NYHA) Class IV congestive heart failure.
• Have severe and uncontrolled hypertension.
• Have active internal bleeding or history of bleeding diathesis.
• Have an increased risk of bleeding.
• Have history of cerebrovascular accidents.
• Have certain abnormal blood level values.
• Are currently receiving chemotherapy or radiation therapy.