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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00059215

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases Heart Diseases	Drug: CS-747 Drug: Clopidogrel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Prasugrel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	900
Study Start Date:	April 2003
Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059215

Locations

United States, Massachusetts
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, United States
Canada, British Columbia
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, Canada

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	7145, H7T-MC-TAAH
Study First Received:	April 21, 2003
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00059215 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Diseases
Therapeutic Uses
Clopidogrel
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009