Back to resultsA Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Primary Purpose
Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Prasugrel (CS-747)
Clopidogrel
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
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
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
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
Number of Participants With Major Adverse Cardiovascular Events (MACE)
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00059215
Brief Title
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Official Title
A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
905 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel (CS-747) 40 mg LD/7.5 mg MD
Arm Type
Experimental
Arm Description
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
Arm Title
Prasugrel (CS-747) 60 mg LD/10 mg MD
Arm Type
Experimental
Arm Description
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
Arm Title
Prasugrel (CS-747) 60 mg LD/15 mg MD
Arm Type
Experimental
Arm Description
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
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
Intervention Type
Drug
Intervention Name(s)
Prasugrel (CS-747)
Other Intervention Name(s)
Prasugrel, LY640315, Effient, Efient
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
Description
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.
Time Frame
randomization though 30 days after percutaneous coronary intervention (PCI)
Secondary Outcome Measure Information:
Title
Number of Participants With Major Adverse Cardiovascular Events (MACE)
Description
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.
Time Frame
randomization though 30 days after percutaneous coronary intervention (PCI)
Title
Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Description
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.
Time Frame
randomization though 30 days after percutaneous coronary intervention (PCI)
Title
Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE
Description
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
Time Frame
randomization though 30 days after percutaneous coronary intervention (PCI)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
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.
City
Victoria
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
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