Clinical trial NCT00133731: The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
Secondary outcomes:
measure: Bleeding events
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Cardiology Associates
state: California
city: Santa Ana
country: United States
facility: Anil V. Shah, MD
state: California
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Atlantis
country: United States
facility: Florida Cardiovascular Research
state: Florida
city: Ocala
country: United States
facility: Ocala Research Institute, Inc
state: Florida
city: Orlando
country: United States
facility: Central Florida Cardiology Group, PA
state: Florida
city: Panama City
country: United States
facility: Cardiology Associates, PA
state: Florida
city: Sarasota
country: United States
facility: Heart Specialists of Sarasota
state: Florida
city: Atlanta
country: United States
facility: Cardiac Disease Specialists
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: Heart Care Midwest
state: Illinois
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center, PC
state: Iowa
city: Wichita
country: United States
facility: Kansas Cardiology Associates
state: Kansas
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Associates
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Plaza Medical Group, PC
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Heart Clinic
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute Inc
state: Texas
city: Houston
country: United States
facility: MEDVAMC
state: Texas
city: San Antonio
country: United States
facility: Audie Murphy VA Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook and Women's College Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Cardiac Catheterization Laboratories of the CHUM
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital St-Luc
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Brno
country: Czech Republic
facility: University Hospital St Anna
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Prague
country: Czech Republic
facility: General University Hospital
city: Prague
country: Czech Republic
facility: University Hospital Motol
city: Bron
country: France
facility: Hopital Cardiologique Louis Pradel
state: Cedex
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
state: Cedex
city: Besancon
country: France
facility: Center Hospitalier Universitaire Jean-Minjoz
city: Nimes
country: France
facility: Clinique Les Franciscaines
city: Paris
country: France
facility: Institut de Cardiologie
city: Alkmaar
country: Germany
facility: Medisch Centrum Alkmarr
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Berlin
country: Germany
facility: Universitatmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukolln
city: Berlin
country: Germany
facility: Virchow-Klinikum, Universtatsmedizin Berlin
city: Duren
country: Germany
facility: Krankanhaus Duren gem.GmbH
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitat
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Gamelinschalftspraxis
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg - Eppendorf
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universitat Jena
city: Koln
country: Germany
facility: Klinikum der Universitat au Koln
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitat Mainz
city: Munchen
country: Germany
facility: Klinik der Universitat Munchen-Grobhadern
city: Schwalmstadt
country: Germany
facility: Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
city: Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Eindhoven
country: Netherlands
facility: Catherine Hospital
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rijnmond-Zuid
city: Zwolle
country: Netherlands
facility: Isala Klinleken, Hospital De Weezenlanden
city: Banska Bystrica
country: Slovakia
facility: Middle Slovak Institute of Cardiovascular Diseases
city: Bratislava
country: Slovakia
facility: Slovak Institute of Cardiovascular Diseases
city: Johannesburg
country: South Africa
facility: Milpark Hospital
city: Kuils River
country: South Africa
facility: Kuils River Private Hospital
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: