A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)

November 2, 2009 updated by: Schering-Plough
The purpose of this research study is to obtain experience in the use of fondaparinux (Arixtra) as compared to heparin when administered to patients who undergo percutaneous coronary intervention (PCI). PCI is a mechanical procedure used to widen the narrowing in a coronary artery in patients with symptomatic coronary artery disease. Fondaparinux and heparin are drugs that inhibit blood clotting.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Hospital
      • Edmonton, Alberta, Canada, T6G 2R7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Hospital & Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QE II Health Sciences Centre, New Halifax Infirmary
    • Ontario
      • Hamilton, Ontario, Canada, L81 2X2
        • HGH-McMaster Clinic
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook & Women's College Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • France
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75018
        • Hôpital Bichat
    • Cedex
      • Besancon, Cedex, France, 25030
        • Hopital Jean Minjoz
      • Caen, Cedex, France, 14033
        • CHU de Caen
      • Dijon, Cedex, France, 21034
        • Hôpital du Bocage
      • Toulouse, Cedex, France, 31043
        • CHU de Rangueil
    • sur Marne
      • Lagny, sur Marne, France, 77405
        • Centre Hospitalier de Lagny-Marne La Vallee
  • United States
    • Florida
      • Ocala, Florida, United States, 34480
        • Ocala Research Institute, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago - Section of Cardiology
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, Dept. of Internal Medicine
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Scheduled for PCI, including PCI for non-ST elevation acute coronary syndromes (ACS), primary PCI for ST elevation myocardial infarction (MI) or elective PCI (with planned overnight stay in hospital). (Patients undergoing diagnostic heart catherization who are suitable candidates for "ad hoc" PCI are also eligible).

Exclusion criteria:

  • Age < 21 years
  • Activated Clotting Time (ACT) > 200 seconds immediately prior to PCI
  • Use of low molecular weight heparin (LMWH) in the previous 6 hours before PCI
  • Currently receiving an oral anticoagulant (OAC) agent with an INR > 1.8
  • Thrombolytic therapy for ST elevation MI in the previous 24 hours before PCI
  • Active internal bleeding or history of hemorrhagic diathesis
  • Thrombocytopenia (platelet count < 100 x 10-9/L)
  • Pregnant women or women of childbearing potential who are not using an effective method of contraception
  • Known allergy to unfractionated heparin, fondaparinux, aspirin or clopidogrel
  • Absolute contra-indication to anticoagulation
  • Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment or prior participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schering-Plough

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Registration Dates

First Submitted

May 7, 2003

First Submitted That Met QC Criteria

May 7, 2003

First Posted (Estimate)

May 8, 2003

Study Record Updates

Last Update Posted (Estimate)

November 3, 2009

Last Update Submitted That Met QC Criteria

November 2, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63133 (ASPIRE-Pilot)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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