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.

Condition	Treatment or Intervention	Phase
Pulmonary Embolism	Drug: SR34006  Drug: (LMW)heparin  Drug: Warfarin VKA  Drug: Acenocoumarol VKA	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

California
      University of California, San Diego Medical Center, San Diego,  California,  United States
      Jerry L. Pettic VA Medical Center, Loma Linda,  California,  United States
Colorado
      University of Colorado Hospital, Denver,  Colorado,  United States
      Anschutz Cancer Pavilion, Aurora,  Colorado,  United States
Florida
      Brandon Regional Hospital, Brandon,  Florida,  33511,  United States
      Bay Pines VA Medical Center, Bay Pines,  Florida,  33744,  United States
      Holmes Regional Medical Center, Melbourne,  Florida,  32901,  United States
      St. Joseph's Hospital, Tampa,  Florida,  33607,  United States
      Jackson Memorial Hospital, Miami,  Florida,  33136,  United States
Georgia
      DeKalb Medical Center, Decatur,  Georgia,  30033,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Loyola University Medical Center and Outpatient Clinic, Maywood,  Illinois,  60153,  United States
Kansas
      Olathe Medical Center, Olathe,  Kansas,  United States
Louisiana
      Christus St. Patrick Hospital, Lake Charles,  Louisiana,  70601,  United States
Maryland
      Sinai Hospital of Baltimore, Baltimore,  Maryland,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
      Boston Medical Center, Boston,  Massachusetts,  United States
Michigan
      William Beaumont Hospital, Troy,  Michigan,  48085,  United States
      St. Joseph Mercy - Oakland, Pontiac,  Michigan,  48341,  United States
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
New Mexico
      Lovelace Health Systems, Clinical Thrombosis Center, Albuquerque,  New Mexico,  87108,  United States
New York
      Mount Sinai School of Medicine, New York,  New York,  United States
      Winthrop University Hospital, Mineola,  New York,  11501,  United States
      Winthrop Pulmonary Associates, Mineola,  New York,  11501,  United States
      St. Luke's-Roosevelt Hospital Center, New York,  New York,  United States
North Carolina
      University of North Carolina Hospitals, Chapel Hill,  North Carolina,  27599,  United States
North Dakota
      Altru Health System Hospital, Grand Forks,  North Dakota,  58201,  United States
Ohio
      Riverside Methodist Hospital, Columbus,  Ohio,  43214,  United States
      Akron General Medical Center, Akron,  Ohio,  44307,  United States
      Medical College of Ohio, Toledo,  Ohio,  43614,  United States
Oklahoma
      INTEGRIS Southwest Medical Center, Oklahoma City,  Oklahoma,  73109,  United States
      Saint Anthony Hospital, Oklahoma City,  Oklahoma,  73101,  United States
      OU Medical Center, Oklahoma City,  Oklahoma,  73104,  United States
      Oklahoma City VA Medical Center, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Crozer-Chester Medical Center, Upland,  Pennsylvania,  19013,  United States
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18105,  United States
South Carolina
      Mary Black Memorial Hospital, Spartanburg,  South Carolina,  29307,  United States
      Spartanburg Regional Medical Center, Spartanburg,  South Carolina,  23903,  United States
Tennessee
      Baptist Memorial Hospital Memphis, Memphis,  Tennessee,  United States
      The West Cancer Clinic, Memphis,  Tennessee,  United States
Texas
      Scott & White Memorial Hospital & Clinic, Temple,  Texas,  76508,  United States
      Northwest Texas Healthcare System, Amarillo,  Texas,  79106,  United States
      The Methodist Hospital, Houston,  Texas,  77030,  United States
      The University of Texas Health Center at Tyler, Tyler,  Texas,  75708,  United States
Utah
      University Hospital, Salt Lake City,  Utah,  United States
Virginia
      McGuire VA Medical Center, Richmond,  Virginia,  23249,  United States
      Inova Alexandria Hospital, Alexandria,  Virginia,  22304,  United States
      Pulmonary Associates of Fredericksburg, Inc., Fredericksburg,  Virginia,  United States
      Portsmouth Pulmonary Associates, Chesapeake,  Virginia,  United States
      Maryview Medical Center, Portsmouth,  Virginia,  United States
      MedSource, Inc., Chesapeake,  Virginia,  United States
Washington
      Swedish Medical Center, Seattle,  Washington,  98122,  United States
      Sacred Heart Medical Center, Spokane,  Washington,  99220,  United States
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
      University of Alberta Hospital, Edmonton,  Alberta,  T6G 2B7,  Canada
Canada, British Columbia
      Kelowna General Hospital, Kelowna,  British Columbia,  V1Y 1T2,  Canada
      St. Paul's Hospital, Vancouver,  British Columbia,  Canada
Canada, Manitoba
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada
Canada, Nova Scotia
      QEII Health Sciences Center, Halifax,  Nova Scotia,  B3H 2Y9,  Canada
Canada, Ontario
      London Health Sciences Centre, London,  Ontario,  N6A 4G5,  Canada
      Ottawa Hospital - Civic Campus, Ottawa,  Ontario,  K1Y 4E9,  Canada
      Hamilton Health Sciences - General Hospital, Hamilton,  Ontario,  Canada
      University Health Network, Toronto General Hospital, Toronto,  Ontario,  Canada
      Humber River Regional Hospital, Weston,  Ontario,  Canada
Canada, Quebec
      Jewish General Hospital, Montreal,  Quebec,  Canada
      Hotel-Dieu de St-Jerome, St-Jerome,  Quebec,  Canada
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

Study ID Numbers:  EFC3484/64714
Record last reviewed:  February 2005
Last Updated:  February 4, 2005
Record first received:  June 16, 2003
ClinicalTrials.gov Identifier:  NCT00062803
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08