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

Cardiovascular Diseases Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059215
• Other study ID #: 7145
• Secondary ID: H7T-MC-TAAH
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2003
• Last updated: May 21, 2010
• Start date: April 2003
• Est. completion date: January 2004

Study information

• Verified date: May 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 905
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Drug:
• Prasugrel (CS-747)
Administered orally
• Clopidogrel
Administered orally

Locations

Country	Name	City	State
Canada	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
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	randomization though 30 days after percutaneous coronary intervention (PCI)	Yes
Secondary	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.	randomization though 30 days after percutaneous coronary intervention (PCI)	No
Secondary	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.	randomization though 30 days after percutaneous coronary intervention (PCI)	Yes
Secondary	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	randomization though 30 days after percutaneous coronary intervention (PCI)	Yes

External Links

•   Lilly Clinical Trial Registry