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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00071279
Registration number
NCT00071279
Ethics application status
Date submitted
16/10/2003
Date registered
20/10/2003
Date last updated
6/04/2011
Titles & IDs
Public title
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
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Scientific title
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
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Secondary ID [1]
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SR34006
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Secondary ID [2]
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EFC5135
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism
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Deep Vein Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Symptomatic recurrent PE/DVT during the 6-month study treatment period.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Major bleeding during the 6-month study treatment period.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2005
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Sample size
Target
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Accrual to date
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Final
1215
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
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Recruitment hospital [2]
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- Premantle, Redcliffe, St. Leonards, South Australia
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Recruitment hospital [3]
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- Ringwood East, Woolloongabba
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Recruitment postcode(s) [1]
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- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
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Recruitment postcode(s) [2]
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- Premantle, Redcliffe, St. Leonards, South Australia
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Recruitment postcode(s) [3]
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- Ringwood East, Woolloongabba
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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Maryland
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Michigan
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New Mexico
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Texas
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Virginia
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United States of America
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Washington
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Austria
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Graz, Wien
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Belgium
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Bruxelles, Duffel, Leuven, Lier, Zottegem
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Brazil
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Porto Alegre, Salvador, Sao Paulo
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Alberta
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Canada
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Canada
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Ontario
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Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno
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Ostrava-Poruba, Plzen, Prague, Usti nad Labem
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Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod
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Kobenhavn, Odense
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Seinajoki
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France
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Besancon, Brest, Chambray les Tours, Clamart, Grenoble
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France
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Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne
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France
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Germany
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Italy
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Treviso, Venezia
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Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem
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Maastricht, Nieuwegein, Sittard, Zwolle
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New Zealand
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Auckland
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Norway
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Oslo, Rud
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Poland
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Bialystok, Szczecin, Warszawa, Wroclaw
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South Africa
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Bloemfontein, Bryanston, Durban
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Spain
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Barcelona, Madrid, Torrelavega, Xativa
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Sweden
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Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00071279
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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ICD CSD
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Address
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Sanofi
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Phone
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00071279
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