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

Lilly

Status and phase

Completed

Phase 2

Conditions

Cardiovascular Diseases

Heart Diseases

Treatments

Drug: Clopidogrel

Drug: Prasugrel (CS-747)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00059215

7145

H7T-MC-TAAH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

905 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

905 participants in 4 patient groups

Prasugrel (CS-747) 40 mg LD/7.5 mg MD

Experimental group

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

Treatment:

Drug: Prasugrel (CS-747)

Prasugrel (CS-747) 60 mg LD/10 mg MD

Experimental group

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

Treatment:

Drug: Prasugrel (CS-747)

Prasugrel (CS-747) 60 mg LD/15 mg MD

Experimental group

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