SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

Last updated: April 5, 2011
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Venous Thrombosis

Chest Pain

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT00071279
EFC5135
SR34006
  • Ages > 18
  • All Genders

Study Summary

Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.

In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Legal age limitations (country specific)

  • Indication for anticoagulation other than PE or DVT

  • Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterialendocarditis

  • Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT studywithin the prior 30 days

  • Life expectancy <3 months

  • Patients in whom anticoagulation treatment for their index PE or DVT should becontinued beyond 6 months

  • Active bleeding or high risk for bleeding

  • Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic bloodpressure > 110 mm Hg

  • Pregnancy, or childbearing potential without proper contraceptive measures, women whoare breastfeeding.

Study Design

Total Participants: 1215
Study Start date:
November 01, 2003
Estimated Completion Date:
December 31, 2005

Connect with a study center

  • Box Hill, Clayton, Coffs Harbour, Garran, Kogarah,
    Australia

    Site Not Available

  • Premantle, Redcliffe, St. Leonards, South Australia,
    Australia

    Site Not Available

  • Ringwood East, Woolloongabba,
    Australia

    Site Not Available

  • Graz, Wien,
    Austria

    Site Not Available

  • Bruxelles, Duffel, Leuven, Lier, Zottegem,
    Belgium

    Site Not Available

  • Porto Alegre, Salvador, Sao Paulo,
    Brazil

    Site Not Available

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • Kelowna General Hospital

    Kelowna, British Columbia
    Canada

    Site Not Available

  • St. Paul's Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • St. Boniface General Hospital

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • The Ottawa Hospital, Civic Campus

    Ottawa, Ontario
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec
    Canada

    Site Not Available

  • Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec

    Sainte-Foy, Quebec
    Canada

    Site Not Available

  • Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno,
    Czech Republic

    Site Not Available

  • Ostrava-Poruba, Plzen, Prague, Usti nad Labem,
    Czech Republic

    Site Not Available

  • Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod,
    Denmark

    Site Not Available

  • Kobenhavn, Odense,
    Denmark

    Site Not Available

  • Seinajoki,
    Finland

    Site Not Available

  • Besancon, Brest, Chambray les Tours, Clamart, Grenoble,
    France

    Site Not Available

  • Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne,
    France

    Site Not Available

  • Toulouse, Valenciennes,
    France

    Site Not Available

  • Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim,
    Germany

    Site Not Available

  • Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia,
    Italy

    Site Not Available

  • Treviso, Venezia,
    Italy

    Site Not Available

  • Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem,
    Netherlands

    Site Not Available

  • Maastricht, Nieuwegein, Sittard, Zwolle,
    Netherlands

    Site Not Available

  • Auckland,
    New Zealand

    Site Not Available

  • Oslo, Rud,
    Norway

    Site Not Available

  • Bialystok, Szczecin, Warszawa, Wroclaw,
    Poland

    Site Not Available

  • Bloemfontein, Bryanston, Durban,
    South Africa

    Site Not Available

  • Barcelona, Madrid, Torrelavega, Xativa,
    Spain

    Site Not Available

  • Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik,
    Sweden

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Bay Pines VA Medical Center

    Bay Pines, Florida
    United States

    Site Not Available

  • Pulmonary Associates of Brandon

    Brandon, Florida
    United States

    Site Not Available

  • Jacksonville Cardiovascular Clinic

    Jacksonville, Florida
    United States

    Site Not Available

  • Melbourne Internal Medicine Associates (MIMA)

    Melbourne, Florida
    United States

    Site Not Available

  • Melbourne Internal Medical Associates (MIMA)

    Palm Bay, Florida
    United States

    Site Not Available

  • Clinical Pharmacology Services

    Tampa, Florida
    United States

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia
    United States

    Site Not Available

  • Cardinal Bernardin Cancer Center

    Maywood, Illinois
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland
    United States

    Site Not Available

  • Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office

    Bloomfield Hills, Michigan
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan
    United States

    Site Not Available

  • St. Joseph Mercy - Oakland

    Pontiac, Michigan
    United States

    Site Not Available

  • St. Joseph Mercy - Oakland Clinical Research Office

    Pontiac, Michigan
    United States

    Site Not Available

  • William Beaumont Hospital / Clinical Research Center

    Royal Oak, Michigan
    United States

    Site Not Available

  • William Beaumont Hospital Troy

    Troy, Michigan
    United States

    Site Not Available

  • Lovelace Sandia Health Systems, Clinical Thrombosis Center

    Albuquerque, New Mexico
    United States

    Site Not Available

  • University of New Mexico Hospital

    Albuquerque, New Mexico
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown, Pennsylvania
    United States

    Site Not Available

  • Crozer-Chester Medical Center

    Upland, Pennsylvania
    United States

    Site Not Available

  • Lung & Chest Medical Associates

    Spartanburg, South Carolina
    United States

    Site Not Available

  • Spartanburg Pharmaceutical Research

    Spartanburg, South Carolina
    United States

    Site Not Available

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina
    United States

    Site Not Available

  • The Methodist Hospital

    Houston, Texas
    United States

    Site Not Available

  • Scott and White Memorial Hospital and Clinic

    Temple, Texas
    United States

    Site Not Available

  • The University of Texas Health Center at Tyler

    Tyler, Texas
    United States

    Site Not Available

  • Inova Alexandria Hospital

    Alexandria, Virginia
    United States

    Site Not Available

  • Pulmonary Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia
    United States

    Site Not Available

  • McGuire VA Medical Center

    Richmond, Virginia
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington
    United States

    Site Not Available

  • Pulmonary Specialists/Spokane Respiratory Consultants

    Spokane, Washington
    United States

    Site Not Available

  • Sacred Heart Medical Center

    Spokane, Washington
    United States

    Site Not Available

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