SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
2 other identifiers
interventional
1,215
19 countries
64
Brief Summary
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo. Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2003
CompletedFirst Posted
Study publicly available on registry
October 20, 2003
CompletedStudy Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 6, 2011
April 1, 2011
2.1 years
October 16, 2003
April 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Secondary Outcomes (1)
Major bleeding during the 6-month study treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
- Written informed consent
You may not qualify if:
- Legal age limitations (country specific)
- Indication for anticoagulation other than PE or DVT
- Creatinine clearance (CLcr) \<10 mL/min, severe hepatic disease, or bacterial endocarditis
- Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
- Life expectancy \<3 months
- Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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, women who are breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (65)
Bay Pines VA Medical Center
Bay Pines, Florida, United States
Pulmonary Associates of Brandon
Brandon, Florida, United States
Jacksonville Cardiovascular Clinic
Jacksonville, Florida, United States
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida, United States
Melbourne Internal Medical Associates (MIMA)
Palm Bay, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
Bloomfield Hills, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Joseph Mercy - Oakland Clinical Research Office
Pontiac, Michigan, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States
William Beaumont Hospital / Clinical Research Center
Royal Oak, Michigan, United States
William Beaumont Hospital Troy
Troy, Michigan, United States
Lovelace Sandia Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, United States
Lung & Chest Medical Associates
Spartanburg, South Carolina, United States
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
The Methodist Hospital
Houston, Texas, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States
The University of Texas Health Center at Tyler
Tyler, Texas, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Pulmonary Specialists/Spokane Respiratory Consultants
Spokane, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Unknown Facility
Box Hill, Clayton, Coffs Harbour, Garran, Kogarah, Australia
Unknown Facility
Premantle, Redcliffe, Saint Leonards, South Australia, Australia
Unknown Facility
Ringwood East, Woolloongabba, Australia
Unknown Facility
Graz, Wien, Austria
Unknown Facility
Bruxelles, Duffel, Leuven, Lier, Zottegem, Belgium
Unknown Facility
Porto Alegre, Salvador, Sao Paulo, Brazil
University of Alberta
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
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
Sainte-Foy, Quebec, Canada
Unknown Facility
Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno, Czechia
Unknown Facility
Ostrava-Poruba, Plzen, Prague, Usti Nad Labem, Czechia
Unknown Facility
Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod, Denmark
Unknown Facility
Kobenhavn, Odense, Denmark
Unknown Facility
Seinäjoki, Finland
Unknown Facility
Besancon, Brest, Chambray Les Tours, Clamart, Grenoble, France
Unknown Facility
Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne, France
Unknown Facility
Toulouse, Valenciennes, France
Unknown Facility
Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim, Germany
Unknown Facility
Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia, Italy
Unknown Facility
Treviso, Venezia, Italy
Unknown Facility
Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem, Netherlands
Unknown Facility
Maastricht, Nieuwegein, Sittard, Zwolle, Netherlands
Unknown Facility
Auckland, New Zealand
Unknown Facility
Oslo, Rud, Norway
Unknown Facility
Bialystok, Szczecin, Warszawa, Wroclaw, Poland
Unknown Facility
Bloemfontein, Bryanston, Durban, South Africa
Unknown Facility
Barcelona, Madrid, Torrelavega, Xativa, Spain
Unknown Facility
Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik, Sweden
Unknown Facility
London, United Kingdom
Related Publications (1)
van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.
PMID: 17855671DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2003
First Posted
October 20, 2003
Study Start
November 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 6, 2011
Record last verified: 2011-04