The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Registration Number
- NCT00133731
- Lead Sponsor
- Sanofi
- Brief Summary
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 947
- 18 years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
- Recent acute coronary syndrome
- Patients at risk for, or with prior recent, bleeding
- Patients have received recent prior treatment with an anticoagulant
- Creatinine clearance > 30 ml/min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
- Secondary Outcome Measures
Name Time Method Bleeding events
Trial Locations
- Locations (89)
Los Angeles Cardiology Associates
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
MEDVAMC
🇺🇸Houston, Texas, United States
Audie Murphy VA Medical Center
🇺🇸San Antonio, Texas, United States
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
University Hospital Motol
🇨🇿Prague, Czech Republic
Middle Slovak Institute of Cardiovascular Diseases
🇸🇰Banska Bystrica, Slovakia
Slovak Institute of Cardiovascular Diseases
🇸🇰Bratislava, Slovakia
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Kansas Cardiology Associates
🇺🇸Wichita, Kansas, United States
Anil V. Shah, MD
🇺🇸Santa Ana, California, United States
Ocala Research Institute, Inc
🇺🇸Ocala, Florida, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Cardiac Disease Specialists
🇺🇸Atlanta, Georgia, United States
Heart Specialists of Sarasota
🇺🇸Sarasota, Florida, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Prairie Cardiovascular Consultants, Ltd
🇺🇸Springfield, Illinois, United States
The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook and Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
UZ Gasthuisberg
🇧🇪Leuven, Belgium
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
CHUM - Hopital St-Luc
🇨🇦Montreal, Quebec, Canada
University Hospital St Anna
🇨🇿Brno, Czech Republic
General University Hospital
🇨🇿Prague, Czech Republic
Institut de Cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
Cardiac Catheterization Laboratories of the CHUM
🇨🇦Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Institut de Cardiologie
🇫🇷Paris, France
Virchow-Klinikum, Universtatsmedizin Berlin
🇩🇪Berlin, Germany
Kerckhoff-Klinik GmbH
🇩🇪Bad Nauheim, Germany
Center Hospitalier Universitaire Jean-Minjoz
🇫🇷Besancon, France
Clinique Les Franciscaines
🇫🇷Nimes, France
Institut Hospitalier Jacques Cartier
🇫🇷Massy, Cedex, France
Klinik der Universitat Munchen-Grobhadern
🇩🇪Munchen, Germany
Milpark Hospital
🇿🇦Johannesburg, South Africa
Kuils River Private Hospital
🇿🇦Kuils River, South Africa
Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
🇩🇪Schwalmstadt, Germany
St Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Medisch Centrum Rijnmond-Zuid
🇳🇱Rotterdam, Netherlands
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Amphia Hospital
🇳🇱Breda, Netherlands
Isala Klinleken, Hospital De Weezenlanden
🇳🇱Zwolle, Netherlands
Segeberger Kliniken GmbH
🇩🇪Segeberg, Germany
Catherine Hospital
🇳🇱Eindhoven, Netherlands
Iowa Heart Center, PC
🇺🇸Des Moines, Iowa, United States
Florida Cardiovascular Research
🇺🇸Atlantis, Florida, United States
Cardiology Associates, PA
🇺🇸Panama City, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Heart Care Midwest
🇺🇸Peoria, Illinois, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Amarillo Heart Clinical Research Institute Inc
🇺🇸Amarillo, Texas, United States
Medisch Centrum Alkmarr
🇩🇪Alkmaar, Germany
Klinikum der Johann Wolfgang Goethe-Universitat
🇩🇪Frankfurt, Germany
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Krankanhaus Duren gem.GmbH
🇩🇪Duren, Germany
Universitatsklinikum Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Klinikum der Friedrich-Schiller-Universitat Jena
🇩🇪Jena, Germany
Gamelinschalftspraxis
🇩🇪Hamburg, Germany
Klinikum der Universitat au Koln
🇩🇪Koln, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪Lubeck, Germany
Johannes Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
Hospital San Juan de Alicante
🇪🇸Alicante, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Gregorio Maranon
🇪🇸Madrid, Spain
Wake Heart Associates
🇺🇸Raleigh, North Carolina, United States
Columbia Heart Clinic
🇺🇸Columbia, South Carolina, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
Plaza Medical Group, PC
🇺🇸Oklahoma City, Oklahoma, United States
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Hopital Cardiologique Louis Pradel
🇫🇷Bron, Cedex, France
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Vivantes Klinikum Neukolln
🇩🇪Berlin, Germany
Universitatmedizin Berlin
🇩🇪Berlin, Germany
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
Central Florida Cardiology Group, PA
🇺🇸Orlando, Florida, United States