A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Cardiovascular Diseases, Heart Diseases

About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria: Patients must be candidates for elective or urgent PCI with intended coronary stenting. Men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age. Exclusion Criteria: Patients must not have planned PCI procedure as initial treatment for an acute ST-elevation acute myocardial infarction (STEMI) Patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study Patients must not have cardiogenic shock or severe congestive heart failure Patients must not have active internal bleeding or history of bleeding diathesis Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or nonhemorrhagic CVA within 2 years of enrollment
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4599) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Prasugrel (CS-747) 40 mg LD/7.5 mg MD
Prasugrel (CS-747) 60 mg LD/10 mg MD
Prasugrel (CS-747) 60 mg LD/15 mg MD
Clopidogrel
Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.