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

Sandra DiGiambattista, MS      610-889-8674 

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

Study ID Numbers:  EFC3484/64714
Record last reviewed:  November 2004
Record first received:  June 16, 2003
ClinicalTrials.gov Identifier:  NCT00062803
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-19