The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
NCT ID: NCT00133731
Last Updated: 2008-07-02
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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COMPLETED
PHASE2
947 participants
INTERVENTIONAL
2004-09-30
2005-10-31
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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Otamixaban (XRP0673)
Unfractionated Heparin
Percutaneous Coronary Intervention
Eligibility Criteria
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Inclusion Criteria
* Due to undergo non-urgent percutaneous coronary intervention (PCI)
* Planned treatment with aspirin and clopidogrel
Exclusion Criteria
* Patients at risk for, or with prior recent, bleeding
* Patients have received recent prior treatment with an anticoagulant
* Creatinine clearance \> 30 ml/min
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Los Angeles Cardiology Associates
Los Angeles, California, United States
Anil V. Shah, MD
Santa Ana, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Florida Cardiovascular Research
Atlantis, Florida, United States
Ocala Research Institute, Inc
Ocala, Florida, United States
Central Florida Cardiology Group, PA
Orlando, Florida, United States
Cardiology Associates, PA
Panama City, Florida, United States
Heart Specialists of Sarasota
Sarasota, Florida, United States
Cardiac Disease Specialists
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Heart Care Midwest
Peoria, Illinois, United States
Prairie Cardiovascular Consultants, Ltd
Springfield, Illinois, United States
The Care Group, LLC
Indianapolis, Indiana, United States
Iowa Heart Center, PC
Des Moines, Iowa, United States
Kansas Cardiology Associates
Wichita, Kansas, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Wake Heart Associates
Raleigh, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Plaza Medical Group, PC
Oklahoma City, Oklahoma, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Columbia Heart Clinic
Columbia, South Carolina, United States
Amarillo Heart Clinical Research Institute Inc
Amarillo, Texas, United States
MEDVAMC
Houston, Texas, United States
Audie Murphy VA Medical Center
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Foothills Medical Center
Calgary, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Cardiac Catheterization Laboratories of the CHUM
Montreal, Quebec, Canada
CHUM - Hopital St-Luc
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
University Hospital St Anna
Brno, , Czechia
University Hospital Hradec Kralove
Hradec Králové, , Czechia
General University Hospital
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
Hopital Cardiologique Louis Pradel
Bron, Cedex, France
Institut Hospitalier Jacques Cartier
Massy, Cedex, France
Center Hospitalier Universitaire Jean-Minjoz
Besançon, , France
Clinique Les Franciscaines
Nîmes, , France
Institut de Cardiologie
Paris, , France
Medisch Centrum Alkmarr
Alkmaar, , Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Universitatmedizin Berlin
Berlin, , Germany
Vivantes Klinikum Neukolln
Berlin, , Germany
Virchow-Klinikum, Universtatsmedizin Berlin
Berlin, , Germany
Klinikum der Universitat au Koln
Cologne, , Germany
Krankanhaus Duren gem.GmbH
Düren, , Germany
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Gamelinschalftspraxis
Hamburg, , Germany
Universitatsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Klinikum der Friedrich-Schiller-Universitat Jena
Jena, , Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, , Germany
Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Klinik der Universitat Munchen-Grobhadern
München, , Germany
Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
Schwalmstadt, , Germany
Segeberger Kliniken GmbH
Segeberg, , Germany
Amphia Hospital
Breda, , Netherlands
Catherine Hospital
Eindhoven, , Netherlands
St Antonius Hospital
Nieuwegein, , Netherlands
Medisch Centrum Rijnmond-Zuid
Rotterdam, , Netherlands
Isala Klinleken, Hospital De Weezenlanden
Zwolle, , Netherlands
Middle Slovak Institute of Cardiovascular Diseases
Banská Bystrica, , Slovakia
Slovak Institute of Cardiovascular Diseases
Bratislava, , Slovakia
Milpark Hospital
Johannesburg, , South Africa
Kuils River Private Hospital
Kuils River, , South Africa
Hospital San Juan de Alicante
Alicante, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari Bellvitge
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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XRP0673
Identifier Type: -
Identifier Source: secondary_id
DRI6199
Identifier Type: -
Identifier Source: org_study_id