SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

April 28, 2009 updated by: Sanofi

The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
  • Australia
      • Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia
      • St. Leonards, South Australia, Australia
  • Austria
      • Graz, Austria
  • Belgium
      • Bruxelles, Charleroi, Leuven, Liege, Yvoir, Belgium
  • Brazil
      • Goiania, Porto Alegre, Sao Paulo, Salvador, Brazil
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1T2
        • Kelowna General Hospital
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Center
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences - General Hospital
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital - Civic Campus
      • Toronto, Ontario, Canada
        • University Health Network, Toronto General Hospital
      • Weston, Ontario, Canada
        • Humber River Regional Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • St-Jerome, Quebec, Canada
        • Hotel-Dieu de St-Jerome
  • Czech Republic
      • Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, Czech Republic
      • Plzen, Czech Republic
  • Denmark
      • Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, Denmark
      • Roskilde, Denmark
  • Finland
      • Hus, Jyvaskyla, Seinajoki, Turku, Finland
  • France
      • Armentieres, Besancon, Bethune, Brest, Chambray Les Tours, France
      • Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix, France
      • Saint Malo, Valenciennes, France
      • Tourcoing, France
  • Germany
      • Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen, Germany
      • Heidelberg, Ibbenburen, Mannheim, Munchen, Germany
  • Italy
      • Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia, Italy
      • Piacenza, Pisa, Reggio Emilia, Treviso, Venezia, Italy
  • Netherlands
      • Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen, Netherlands
      • Haarlem, Maastricht, Nieuwegein, Netherlands
  • Norway
      • Oslo, Rud, Norway
  • Poland
      • Lublin, Warszawa, Wroclaw, Poland
  • Spain
      • Badalona, Madrid, Sevilla, Spain
  • Sweden
      • Goteborg, Jonkoping, Stockholm, Varnamo, Sweden
  • Switzerland
      • Basel, Bern, Lugano, Switzerland
  • United Kingdom
      • London, United Kingdom
  • United States
    • California
      • Loma Linda, California, United States
        • Jerry L. Pettic VA Medical Center
      • San Diego, California, United States
        • University of California, San Diego Medical Center
    • Colorado
      • Aurora, Colorado, United States
        • Anschutz Cancer Pavilion
      • Denver, Colorado, United States
        • University of Colorado Hospital
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Medical Center
      • Brandon, Florida, United States, 33511
        • Brandon Regional Hospital
      • Melbourne, Florida, United States, 32901
        • Holmes Regional Medical Center
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Hospital
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center and Outpatient Clinic
    • Kansas
      • Olathe, Kansas, United States
        • Olathe Medical Center
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Christus St. Patrick Hospital
    • Maryland
      • Baltimore, Maryland, United States
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy - Oakland
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Health Systems, Clinical Thrombosis Center
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • Mineola, New York, United States, 11501
        • Winthrop Pulmonary Associates
      • New York, New York, United States
        • Mount Sinai School of Medicine
      • New York, New York, United States
        • St. Luke's-Roosevelt Hospital Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Altru Health System Hospital
    • Ohio
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Toledo, Ohio, United States, 43614
        • Medical College of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center
      • Oklahoma City, Oklahoma, United States, 73109
        • Integris Southwest Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma City VA Medical Center
      • Oklahoma City, Oklahoma, United States, 73101
        • Saint Anthony Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Hospital
      • Upland, Pennsylvania, United States, 19013
        • Crozer-Chester Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 23903
        • Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Mary Black Memorial Hospital
    • Tennessee
      • Memphis, Tennessee, United States
        • Baptist Memorial Hospital Memphis
      • Memphis, Tennessee, United States
        • The West Cancer Clinic
    • Texas
      • Amarillo, Texas, United States, 79106
        • Northwest Texas Healthcare System
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital & Clinic
      • Tyler, Texas, United States, 75708
        • The University of Texas Health Center at Tyler
    • Utah
      • Salt Lake City, Utah, United States
        • University Hospital
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Inova Alexandria Hospital
      • Chesapeake, Virginia, United States
        • MedSource, Inc.
      • Chesapeake, Virginia, United States
        • Portsmouth Pulmonary Associates
      • Fredericksburg, Virginia, United States
        • Pulmonary Associates of Fredericksburg, Inc.
      • Portsmouth, Virginia, United States
        • Maryview Medical Center
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Spokane, Washington, United States, 99220
        • Sacred Heart Medical Center

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:

  • Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
  • Written informed consent

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
  • Other indication for VKA than PE/DVT
  • More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
  • Participation in another pharmacotherapeutic study within the prior 30 days
  • Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis
  • Life expectancy <3 months
  • Active bleeding or high risk for bleeding
  • Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg
  • Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
  • Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary Outcome Measures

Outcome Measure
symptomatic recurrent PE/DVT within 6 months.

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.

General Publications

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

June 1, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

June 16, 2003

First Submitted That Met QC Criteria

June 16, 2003

First Posted (Estimate)

June 17, 2003

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC3484

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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