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

Phase 2

Completed

• Conditions: Cardiovascular Diseases; Heart Diseases
• Interventions: Drug: Prasugrel (CS-747); Drug: Clopidogrel

• Registration Number: NCT00059215
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-04-21
• Study First Submitted QC: 2003-04-22
• Study First Posted: 2003-04-23
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Results First Submitted: 2010-04-19
• Results First Submitted QC: 2010-04-19
• Status Verified: 2010-05
• Results First Posted: 2010-05-21
• Last Update Submitted: 2010-05-21
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 905

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel (CS-747) 60 mg LD/15 mg MD	Prasugrel (CS-747)	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
Prasugrel (CS-747) 40 mg LD/7.5 mg MD	Prasugrel (CS-747)	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 LD/10 mg MD	Prasugrel (CS-747)	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
Clopidogrel	Clopidogrel	Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events	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 Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Cardiovascular Events (MACE)	randomization though 30 days after percutaneous coronary intervention (PCI)	Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.
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-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.
Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus 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 or Minor bleeding or MACE.; Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin.; Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.; MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization

Trial Locations

Locations (2)

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.; 🇺🇸 Boston, Massachusetts, United States

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.; 🇨🇦 Victoria, British Columbia, Canada