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A Trial of CS-747 Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)
This study has been completed.
First Received: April 21, 2003   Last Updated: July 14, 2009   History of Changes
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:


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:
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