Expired Study
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Boston, Massachusetts


Purpose:

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.


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


Study is Available At:


Original ID:

7145


NCT ID:

NCT00059215


Secondary ID:

H7T-MC-TAAH


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

905


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:April 2003
Completion Date:January 2004
Completion Type:Actual
Primary Completion Date:January 2004
Primary Completion Type:Actual
Verification Date:May 2010
Last Changed Date:May 21, 2010
First Received Date:April 21, 2003
First Results Date:April 19, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure: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)
Safety Issues:True
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 decre
Outcome Type:Secondary Outcome
Measure:Number of Participants With Major Adverse Cardiovascular Events (MACE)
Time Frame:randomization though 30 days after percutaneous coronary intervention (PCI)
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Time Frame:randomization though 30 days after percutaneous coronary intervention (PCI)
Safety Issues:True
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 decre
Outcome Type:Secondary Outcome
Measure:Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE
Time Frame:randomization though 30 days after percutaneous coronary intervention (PCI)
Safety Issues:True
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

Study Interventions

Intervention Type:Drug
Name:Prasugrel (CS-747)
Description:Administered orally
Arm Name:Prasugrel (CS-747) 40 mg LD/7.5 mg MD
Other Name:Prasugrel
Intervention Type:Drug
Name:Clopidogrel
Description:Administered orally
Arm Name:Clopidogrel

Study Arms

Study Arm Type:Experimental
Arm Name:Prasugrel (CS-747) 40 mg LD/7.5 mg MD
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
Study Arm Type:Experimental
Arm Name:Prasugrel (CS-747) 60 mg LD/10 mg MD
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
Study Arm Type:Experimental
Arm Name:Prasugrel (CS-747) 60 mg LD/15 mg MD
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
Study Arm Type:Active Comparator
Arm Name:Clopidogrel
Description:Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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