A Safety and Efficacy Trial Evaluating the Use of Fondaparinux in Percutaneous Coronary Intervention (PCI)(63133)(WITHDRAWN)
NCT ID: NCT00060554
Last Updated: 2009-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
300 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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fondaparinux sodium
heparin
percutaneous coronary intervention (PCI)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
21 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Responsible Party
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Schering-Plough
Locations
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Ocala Research Institute, Inc.
Ocala, Florida, United States
University of Chicago - Section of Cardiology
Chicago, Illinois, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan, Dept. of Internal Medicine
Ann Arbor, Michigan, United States
Greenville Hospital System
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Methodist Hospital
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Foothills Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Hospital & Health Sciences Centre
Vancouver, British Columbia, Canada
QE II Health Sciences Centre, New Halifax Infirmary
Halifax, Nova Scotia, Canada
HGH-McMaster Clinic
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Hopital Jean Minjoz
Besançon, Cedex, France
CHU de Caen
Caen, Cedex, France
Hopital du Bocage
Dijon, Cedex, France
CHU de Rangueil
Toulouse, Cedex, France
Centre Hospitalier de Lagny-Marne La Vallee
Lagny, Sur Marne, France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat
Paris, , France
Countries
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Other Identifiers
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63133 (ASPIRE-Pilot)
Identifier Type: -
Identifier Source: org_study_id
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