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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

905 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

Prasugrel (CS-747)

Intervention Type DRUG

Administered orally

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

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

Group Type EXPERIMENTAL

Prasugrel (CS-747)

Intervention Type DRUG

Administered orally

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

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

Group Type EXPERIMENTAL

Prasugrel (CS-747)

Intervention Type DRUG

Administered orally

Clopidogrel

Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Administered orally

Interventions

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Prasugrel (CS-747)

Administered orally

Intervention Type DRUG

Clopidogrel

Administered orally

Intervention Type DRUG

Other Intervention Names

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Prasugrel LY640315 Effient Efient

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No