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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Heart Diseases   

ChemIDplus related topics:   Clopidogrel    Clopidogrel Bisulfate    Prasugrel   

U.S. FDA Resources

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

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

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

Study ID Numbers:   7145, H7T-MC-TAAH
First Received:   April 21, 2003
Last Updated:   June 15, 2007
ClinicalTrials.gov Identifier:   NCT00059215
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Heart Diseases
Clopidogrel

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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