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
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.
Inclusion Criteria:
Exclusion Criteria:
Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia
Bruxelles, Charleroi, Leuven, Liege, Yvoir, Belgium
Goiania, Porto Alegre, Sao Paulo, Salvador, Brazil
Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, Czechia
Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, 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
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