SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
NCT ID: NCT00062803
Last Updated: 2009-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2003-06-30
2005-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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SR34006
(LMW)heparin
Warfarin VKA
Acenocoumarol VKA
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Jerry L. Pettic VA Medical Center
Loma Linda, California, United States
University of California, San Diego Medical Center
San Diego, California, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
University of Colorado Hospital
Denver, Colorado, United States
Bay Pines VA Medical Center
Bay Pines, Florida, United States
Brandon Regional Hospital
Brandon, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
DeKalb Medical Center
Decatur, Georgia, United States
Loyola University Medical Center and Outpatient Clinic
Maywood, Illinois, United States
Olathe Medical Center
Olathe, Kansas, United States
Christus St. Patrick Hospital
Lake Charles, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Lovelace Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico, United States
Winthrop Pulmonary Associates
Mineola, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Altru Health System Hospital
Grand Forks, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Medical College of Ohio
Toledo, Ohio, United States
Saint Anthony Hospital
Oklahoma City, Oklahoma, United States
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States
OU Medical Center
Oklahoma City, Oklahoma, United States
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Mary Black Memorial Hospital
Spartanburg, South Carolina, United States
Baptist Memorial Hospital Memphis
Memphis, Tennessee, United States
The West Cancer Clinic
Memphis, Tennessee, United States
Northwest Texas Healthcare System
Amarillo, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Scott & White Memorial Hospital & Clinic
Temple, Texas, United States
The University of Texas Health Center at Tyler
Tyler, Texas, United States
University Hospital
Salt Lake City, Utah, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
MedSource, Inc.
Chesapeake, Virginia, United States
Portsmouth Pulmonary Associates
Chesapeake, Virginia, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
Maryview Medical Center
Portsmouth, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Buenos Aires, , Argentina
Box Hill, Clayton, Garran, Kogarah, Ringwood East, , Australia
Saint Leonards, South Australia, , Australia
Graz, , Austria
Bruxelles, Charleroi, Leuven, Liege, Yvoir, , Belgium
Goiania, Porto Alegre, Sao Paulo, Salvador, , Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
Humber River Regional Hospital
Weston, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec, Canada
Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, , Czechia
Pilsen, , Czechia
Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, , Denmark
Roskilde, , Denmark
Hus, Jyvaskyla, Seinajoki, Turku, , Finland
Armentieres, Besancon, Bethune, Brest, Chambray Les Tours, , France
Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix, , France
Saint Malo, Valenciennes, , France
Tourcoing, , France
Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen, , Germany
Heidelberg, Ibbenburen, Mannheim, Munchen, , Germany
Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia, , Italy
Piacenza, Pisa, Reggio Emilia, Treviso, Venezia, , Italy
Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen, , Netherlands
Haarlem, Maastricht, Nieuwegein, , Netherlands
Oslo, Rud, , Norway
Lublin, Warszawa, Wroclaw, , Poland
Badalona, Madrid, Sevilla, , Spain
Goteborg, Jonkoping, Stockholm, Varnamo, , Sweden
Basel, Bern, Lugano, , Switzerland
London, , United Kingdom
Countries
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References
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Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.
Related Links
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Related Info
Other Identifiers
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EFC3484
Identifier Type: -
Identifier Source: org_study_id
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