The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention (SEPIA-PCI)

July 1, 2008 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

947

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium, 3000
        • Uz Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 219
        • Foothills Medical Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal
      • Montreal, Quebec, Canada, H2L 4MI
        • Cardiac Catheterization Laboratories of the CHUM
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - Hopital St-Luc
      • Montreal, Quebec, Canada, H4J IC5
        • Hopital du Sacre-Coeur de Montreal
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • University Hospital St Anna
      • Hradec Kralove, Czech Republic, 408
        • University Hospital Hradec Kralove
      • Prague, Czech Republic, 2, 120 08
        • General University Hospital
      • Prague, Czech Republic, 5, 150 06
        • University Hospital Motol
  • France
      • Besancon, France, 25030
        • Center Hospitalier Universitaire Jean-Minjoz
      • Nimes, France, 30000
        • Clinique Les Franciscaines
      • Paris, France, 75013
        • Institut de Cardiologie
    • Cedex
      • Bron, Cedex, France, 69677
        • Hôpital Cardiologique Louis Pradel
      • Massy, Cedex, France, 91949
        • Institut Hospitalier Jacques Cartier
  • Germany
      • Alkmaar, Germany, 1815 JD
        • Medisch Centrum Alkmarr
      • Bad Nauheim, Germany, D-61231
        • Kerckhoff-Klinik GmbH
      • Berlin, Germany, D-12351
        • Vivantes Klinikum Neukölln
      • Berlin, Germany, D-12200
        • Universitatmedizin Berlin
      • Berlin, Germany, D-13353
        • Virchow-Klinikum, Universtatsmedizin Berlin
      • Duren, Germany, 52351
        • Krankanhaus Duren gem.GmbH
      • Frankfurt, Germany, D-60590
        • Klinikum der Johann Wolfgang Goethe-Universität
      • Freiburg, Germany, D-79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 22763
        • Gamelinschalftspraxis
      • Hamburg, Germany, D-20246
        • Universitätsklinikum Hamburg - Eppendorf
      • Jena, Germany, 07740
        • Klinikum der Friedrich-Schiller-Universität Jena
      • Koln, Germany, D-50924
        • Klinikum der Universitat au Koln
      • Lubeck, Germany, D-23538
        • Universitätsklinikum Schleswig-Holstein
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universitat Mainz
      • Munchen, Germany, D-81377
        • Klinik der Universitat Munchen-Grobhadern
      • Schwalmstadt, Germany, D-34613
        • Klinikum Schwalmstadt der Schwalm-Eder-Kliniken
      • Segeberg, Germany, D-23795
        • Segeberger Kliniken Gmbh
  • Netherlands
      • Breda, Netherlands, 4836 AE
        • Amphia Hospital
      • Eindhoven, Netherlands, 5823 EJ
        • Catherine Hospital
      • Nieuwegein, Netherlands, 3435 CM
        • St Antonius hospital
      • Rotterdam, Netherlands, 3075 EA
        • Medisch Centrum Rijnmond-Zuid
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinleken, Hospital De Weezenlanden
  • Slovakia
      • Banska Bystrica, Slovakia
        • Middle Slovak Institute of Cardiovascular Diseases
      • Bratislava, Slovakia
        • Slovak Institute of Cardiovascular Diseases
  • South Africa
      • Johannesburg, South Africa
        • Milpark Hospital
      • Kuils River, South Africa, 7580
        • Kuils River Private Hospital
  • Spain
      • Alicante, Spain, 03550
        • Hospital San Juan de Alicante
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28807
        • Hospital Gregorio Marañón
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
  • United States
    • California
      • Los Angeles, California, United States, 90017
        • Los Angeles Cardiology Associates
      • Santa Ana, California, United States, 92704
        • Anil V. Shah, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Faculty Associates
    • Florida
      • Atlantis, Florida, United States, 33462
        • Florida Cardiovascular Research
      • Ocala, Florida, United States, 34480
        • Ocala Research Institute, Inc
      • Orlando, Florida, United States, 32803
        • Central Florida Cardiology Group, PA
      • Panama City, Florida, United States, 32401
        • Cardiology Associates, PA
      • Sarasota, Florida, United States, 34239
        • Heart Specialists of Sarasota
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Cardiac Disease Specialists
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Foundation
      • Maywood, Illinois, United States, 61053
        • Loyola University Medical Center
      • Peoria, Illinois, United States, 61603
        • Heart Care Midwest
      • Springfield, Illinois, United States, 62702
        • Prairie Cardiovascular Consultants, Ltd
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Care Group, Llc
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center, PC
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Kansas Cardiology Associates
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605-0002
        • Umass Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • LeBauer Cardiovascular Research Foundation
      • Raleigh, North Carolina, United States, 27610
        • Wake Heart Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
      • Oklahoma City, Oklahoma, United States, 73112
        • Plaza Medical Group, Pc
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2160
        • Geisinger Clinic
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Heart Clinic
    • Texas
      • Amarillo, Texas, United States, 79106
        • Amarillo Heart Clinical Research Institute Inc
      • Houston, Texas, United States, 77030
        • MEDVAMC
      • San Antonio, Texas, United States, 78229
        • Audie Murphy VA Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298-0036
        • Virginia Commonwealth University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization

Secondary Outcome Measures

Outcome Measure
Bleeding events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

July 2, 2008

Last Update Submitted That Met QC Criteria

July 1, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI6199
  • XRP0673

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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