The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
SEPIA-PCI
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
2 other identifiers
interventional
947
10 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2004
Shorter than P25 for phase_2
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJuly 2, 2008
June 1, 2008
August 23, 2005
July 1, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
Secondary Outcomes (1)
Bleeding events
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Due to undergo non-urgent percutaneous coronary intervention (PCI)
- Planned treatment with aspirin and clopidogrel
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (89)
Los Angeles Cardiology Associates
Los Angeles, California, 90017, United States
Anil V. Shah, MD
Santa Ana, California, 92704, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Florida Cardiovascular Research
Atlantis, Florida, 33462, United States
Ocala Research Institute, Inc
Ocala, Florida, 34480, United States
Central Florida Cardiology Group, PA
Orlando, Florida, 32803, United States
Cardiology Associates, PA
Panama City, Florida, 32401, United States
Heart Specialists of Sarasota
Sarasota, Florida, 34239, United States
Cardiac Disease Specialists
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Heart Foundation
Lombard, Illinois, 60148, United States
Loyola University Medical Center
Maywood, Illinois, 61053, United States
Heart Care Midwest
Peoria, Illinois, 61603, United States
Prairie Cardiovascular Consultants, Ltd
Springfield, Illinois, 62702, United States
The Care Group, LLC
Indianapolis, Indiana, 46290, United States
Iowa Heart Center, PC
Des Moines, Iowa, 50314, United States
Kansas Cardiology Associates
Wichita, Kansas, 67214, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605-0002, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401, United States
Wake Heart Associates
Raleigh, North Carolina, 27610, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Plaza Medical Group, PC
Oklahoma City, Oklahoma, 73112, United States
Geisinger Clinic
Danville, Pennsylvania, 17822-2160, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Columbia Heart Clinic
Columbia, South Carolina, 29203, United States
Amarillo Heart Clinical Research Institute Inc
Amarillo, Texas, 79106, United States
MEDVAMC
Houston, Texas, 77030, United States
Audie Murphy VA Medical Center
San Antonio, Texas, 78229, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0036, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gasthuisberg
Leuven, 3000, Belgium
Foothills Medical Center
Calgary, Alberta, T2N 219, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Cardiac Catheterization Laboratories of the CHUM
Montreal, Quebec, H2L 4MI, Canada
CHUM - Hopital St-Luc
Montreal, Quebec, H2X 3J4, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J IC5, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
University Hospital St Anna
Brno, 656 91, Czechia
University Hospital Hradec Kralove
Hradec Králové, 408, Czechia
General University Hospital
Prague, 2, 120 08, Czechia
University Hospital Motol
Prague, 5, 150 06, Czechia
Hopital Cardiologique Louis Pradel
Bron, Cedex, 69677, France
Institut Hospitalier Jacques Cartier
Massy, Cedex, 91949, France
Center Hospitalier Universitaire Jean-Minjoz
Besançon, 25030, France
Clinique Les Franciscaines
Nîmes, 30000, France
Institut de Cardiologie
Paris, 75013, France
Medisch Centrum Alkmarr
Alkmaar, 1815 JD, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, D-61231, Germany
Universitatmedizin Berlin
Berlin, D-12200, Germany
Vivantes Klinikum Neukolln
Berlin, D-12351, Germany
Virchow-Klinikum, Universtatsmedizin Berlin
Berlin, D-13353, Germany
Klinikum der Universitat au Koln
Cologne, D-50924, Germany
Krankanhaus Duren gem.GmbH
Düren, 52351, Germany
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt, D-60590, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, D-79106, Germany
Gamelinschalftspraxis
Hamburg, 22763, Germany
Universitatsklinikum Hamburg - Eppendorf
Hamburg, D-20246, Germany
Klinikum der Friedrich-Schiller-Universitat Jena
Jena, 07740, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, D-23538, Germany
Johannes Gutenberg Universitat Mainz
Mainz, 55131, Germany
Klinik der Universitat Munchen-Grobhadern
München, D-81377, Germany
Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
Schwalmstadt, D-34613, Germany
Segeberger Kliniken GmbH
Segeberg, D-23795, Germany
Amphia Hospital
Breda, 4836 AE, Netherlands
Catherine Hospital
Eindhoven, 5823 EJ, Netherlands
St Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Medisch Centrum Rijnmond-Zuid
Rotterdam, 3075 EA, Netherlands
Isala Klinleken, Hospital De Weezenlanden
Zwolle, 8011 JW, 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, 7580, South Africa
Hospital San Juan de Alicante
Alicante, 03550, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitari Bellvitge
Barcelona, 08907, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Gregorio Maranon
Madrid, 28807, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 24, 2005
Study Start
September 1, 2004
Study Completion
October 1, 2005
Last Updated
July 2, 2008
Record last verified: 2008-06