Angioplasty, Transluminal, Percutaneous Coronary Clinical Trial
— SEPIA-PCIOfficial title:
A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
| Verified date | June 2008 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 947 |
| Est. completion date | October 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years of age or older - Due to undergo non-urgent percutaneous coronary intervention (PCI) - Planned treatment with aspirin and clopidogrel Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | Foothills Medical Center | Calgary | Alberta |
| 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 | Institut de Cardiologie de Montreal | Montreal | Quebec |
| Canada | Southlake Regional Health Centre | Newmarket | Ontario |
| Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
| Canada | Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario |
| Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
| Czech Republic | University Hospital St Anna | Brno | |
| Czech Republic | University Hospital Hradec Kralove | Hradec Kralove | |
| Czech Republic | General University Hospital | Prague | |
| Czech Republic | University Hospital Motol | Prague | |
| France | Center Hospitalier Universitaire Jean-Minjoz | Besancon | |
| France | Hopital Cardiologique Louis Pradel | Bron | Cedex |
| France | Institut Hospitalier Jacques Cartier | Massy | Cedex |
| France | Clinique Les Franciscaines | Nimes | |
| France | Institut de Cardiologie | Paris | |
| Germany | Medisch Centrum Alkmarr | Alkmaar | |
| Germany | Kerckhoff-Klinik GmbH | Bad Nauheim | |
| Germany | Universitatmedizin Berlin | Berlin | |
| Germany | Virchow-Klinikum, Universtatsmedizin Berlin | Berlin | |
| Germany | Vivantes Klinikum Neukolln | Berlin | |
| Germany | Krankanhaus Duren gem.GmbH | Duren | |
| Germany | Klinikum der Johann Wolfgang Goethe-Universitat | Frankfurt | |
| Germany | Universitatsklinikum Freiburg | Freiburg | |
| Germany | Gamelinschalftspraxis | Hamburg | |
| Germany | Universitatsklinikum Hamburg - Eppendorf | Hamburg | |
| Germany | Klinikum der Friedrich-Schiller-Universitat Jena | Jena | |
| Germany | Klinikum der Universitat au Koln | Koln | |
| Germany | Universitatsklinikum Schleswig-Holstein | Lubeck | |
| Germany | Johannes Gutenberg Universitat Mainz | Mainz | |
| Germany | Klinik der Universitat Munchen-Grobhadern | Munchen | |
| Germany | Klinikum Schwalmstadt der Schwalm-Eder-Kliniken | Schwalmstadt | |
| Germany | Segeberger Kliniken GmbH | Segeberg | |
| Netherlands | 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 | |
| Slovakia | Middle Slovak Institute of Cardiovascular Diseases | Banska Bystrica | |
| Slovakia | Slovak Institute of Cardiovascular Diseases | Bratislava | |
| South Africa | Milpark Hospital | Johannesburg | |
| South Africa | Kuils River Private Hospital | Kuils River | |
| Spain | 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 | Malaga | |
| United States | Amarillo Heart Clinical Research Institute Inc | Amarillo | Texas |
| United States | Cardiac Disease Specialists | Atlanta | Georgia |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | Florida Cardiovascular Research | Atlantis | Florida |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Columbia Heart Clinic | Columbia | South Carolina |
| United States | Geisinger Clinic | Danville | Pennsylvania |
| United States | Iowa Heart Center, PC | Des Moines | Iowa |
| United States | LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina |
| United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | MEDVAMC | Houston | Texas |
| United States | The Care Group, LLC | Indianapolis | Indiana |
| United States | Midwest Heart Foundation | Lombard | Illinois |
| United States | Los Angeles Cardiology Associates | Los Angeles | California |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
| United States | Newark Beth Israel Medical Center | Newark | New Jersey |
| United States | Ocala Research Institute, Inc | Ocala | Florida |
| United States | Plaza Medical Group, PC | Oklahoma City | Oklahoma |
| United States | University of Oklahoma Health Science Center | Oklahoma City | Oklahoma |
| United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
| United States | Central Florida Cardiology Group, PA | Orlando | Florida |
| United States | Cardiology Associates, PA | Panama City | Florida |
| United States | Heart Care Midwest | Peoria | Illinois |
| United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
| United States | Wake Heart Associates | Raleigh | North Carolina |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Audie Murphy VA Medical Center | San Antonio | Texas |
| United States | Anil V. Shah, MD | Santa Ana | California |
| United States | Heart Specialists of Sarasota | Sarasota | Florida |
| United States | Prairie Cardiovascular Consultants, Ltd | Springfield | Illinois |
| United States | George Washington University Medical Faculty Associates | Washington | District of Columbia |
| United States | Kansas Cardiology Associates | Wichita | Kansas |
| United States | UMass Memorial Medical Center | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Belgium, Canada, Czech Republic, France, Germany, Netherlands, Slovakia, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Death, myocardial infarction, and urgent and non-urgent target vessel revascularization | |||
| Secondary | Bleeding events |
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