Clinical trial NCT00062803: SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Embolism
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-06-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary outcomes:
measure: symptomatic recurrent PE/DVT within 6 months.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Jerry L. Pettic VA Medical Center
state: California
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion
state: Colorado
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Bay Pines
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Brandon
country: United States
facility: Brandon Regional Hospital
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Center
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center and Outpatient Clinic
state: Illinois
city: Olathe
country: United States
facility: Olathe Medical Center
state: Kansas
city: Lake Charles
country: United States
facility: Christus St. Patrick Hospital
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Albuquerque
country: United States
facility: Lovelace Health Systems, Clinical Thrombosis Center
state: New Mexico
city: Mineola
country: United States
facility: Winthrop Pulmonary Associates
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System Hospital
state: North Dakota
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Saint Anthony Hospital
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: INTEGRIS Southwest Medical Center
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Upland
country: United States
facility: Crozer-Chester Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Spartanburg
country: United States
facility: Mary Black Memorial Hospital
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital Memphis
state: Tennessee
city: Memphis
country: United States
facility: The West Cancer Clinic
state: Tennessee
city: Amarillo
country: United States
facility: Northwest Texas Healthcare System
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital & Clinic
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Center at Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University Hospital
state: Utah
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Chesapeake
country: United States
facility: MedSource, Inc.
state: Virginia
city: Chesapeake
country: United States
facility: Portsmouth Pulmonary Associates
state: Virginia
city: Fredericksburg
country: United States
facility: Pulmonary Associates of Fredericksburg, Inc.
state: Virginia
city: Portsmouth
country: United States
facility: Maryview Medical Center
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Buenos Aires
country: Argentina
city: Box Hill, Clayton, Garran, Kogarah, Ringwood East
country: Australia
city: St. Leonards, South Australia
country: Australia
city: Graz
country: Austria
city: Bruxelles, Charleroi, Leuven, Liege, Yvoir
country: Belgium
city: Goiania, Porto Alegre, Sao Paulo, Salvador
country: Brazil
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
city: Weston
country: Canada
facility: Humber River Regional Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: St-Jerome
country: Canada
facility: Hotel-Dieu de St-Jerome
state: Quebec
city: Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague
country: Czech Republic
city: Plzen
country: Czech Republic
city: Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense
country: Denmark
city: Roskilde
country: Denmark
city: Hus, Jyvaskyla, Seinajoki, Turku
country: Finland
city: Armentieres, Besancon, Bethune, Brest, Chambray Les Tours
country: France
city: Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix
country: France
city: Saint Malo, Valenciennes
country: France
city: Tourcoing
country: France
city: Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen
country: Germany
city: Heidelberg, Ibbenburen, Mannheim, Munchen
country: Germany
city: Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia
country: Italy
city: Piacenza, Pisa, Reggio Emilia, Treviso, Venezia
country: Italy
city: Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen
country: Netherlands
city: Haarlem, Maastricht, Nieuwegein
country: Netherlands
city: Oslo, Rud
country: Norway
city: Lublin, Warszawa, Wroclaw
country: Poland
city: Badalona, Madrid, Sevilla
country: Spain
city: Goteborg, Jonkoping, Stockholm, Varnamo
country: Sweden
city: Basel, Bern, Lugano
country: Switzerland
city: London
country: United Kingdom
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.