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

Tracking Information

First Received Date ^ICMJE

April 21, 2003

Last Updated Date

July 14, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To evaluate the safety of increasing doses of CS-747 (a loading dose during PCI and 29 to 34 days of once-daily maintenance dosing) by observing the rate of noncoronary artery bypass graft (non-CABG)-associated significant bleeding. [ Time Frame: 30-35 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00059215 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety and efficacy of increasing doses of CS-747 by observing the following endpoints at 30 to 35 days after PCI: non-CABG-associated major bleeding, major adverse cardiovascular events, and non-CABG major plus minor bleeding. [ Time Frame: 30-35 days ]

Original Secondary Outcome Measures ^ICMJE

To evaluate the safety and efficacy of increasing doses of CS-747 by observing the following endpoints at 30 to 35 days after PCI: non–CABG-associated major bleeding, major adverse cardiovascular events, and non–CABG major plus minor bleeding. [ Time Frame: 30-35 days ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to evaluate the effects of a drug known as CS-747 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cardiovascular Diseases
Heart Diseases

Intervention ^ICMJE

Drug: CS-747
Drug: Clopidogrel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

900

Completion Date

January 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00059215

Responsible Party

Study ID Numbers ^ICMJE

7145, H7T-MC-TAAH

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP