A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention
Overview
- Phase
- Phase 2
- Intervention
- Prasugrel (CS-747)
- Conditions
- Cardiovascular Diseases
- Sponsor
- Eli Lilly and Company
- Enrollment
- 905
- Locations
- 2
- Primary Endpoint
- Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
Investigators
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
Arms & Interventions
Prasugrel (CS-747) 40 mg LD/7.5 mg MD
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
Intervention: Prasugrel (CS-747)
Prasugrel (CS-747) 60 mg LD/10 mg MD
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
Intervention: Prasugrel (CS-747)
Prasugrel (CS-747) 60 mg LD/15 mg MD
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
Intervention: Prasugrel (CS-747)
Clopidogrel
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
Intervention: Clopidogrel
Outcomes
Primary Outcomes
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
Time Frame: randomization though 30 days after percutaneous coronary intervention (PCI)
Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.
Secondary Outcomes
- Number of Participants With Major Adverse Cardiovascular Events (MACE)(randomization though 30 days after percutaneous coronary intervention (PCI))
- Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding(randomization though 30 days after percutaneous coronary intervention (PCI))
- Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE(randomization though 30 days after percutaneous coronary intervention (PCI))