drugset / Trial / NCT00059215

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

NCT00059215 ↗

Phase 2 Completed 905 enrolled Eli Lilly and Company
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2003-04
Primary completion
2004-01
Completion
2004-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Clopidogrel vs Prasugrel (CS-747) Combined; p = 0.590; Log Rank NCT00059215 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg Oral
Subject Prasugrel Small molecule 7.5 mg Oral
Subject Prasugrel Small molecule 10 mg Oral
Subject Prasugrel Small molecule 15 mg Oral

Indications