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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
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
Secondary ID [1] 0 0
SR34006
Secondary ID [2] 0 0
EFC5135
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Major bleeding during the 6-month study treatment period.
Timepoint [1] 0 0

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
1215
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
Recruitment hospital [2] 0 0
- Premantle, Redcliffe, St. Leonards, South Australia
Recruitment hospital [3] 0 0
- Ringwood East, Woolloongabba
Recruitment postcode(s) [1] 0 0
- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
Recruitment postcode(s) [2] 0 0
- Premantle, Redcliffe, St. Leonards, South Australia
Recruitment postcode(s) [3] 0 0
- Ringwood East, Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Graz, Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles, Duffel, Leuven, Lier, Zottegem
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre, Salvador, Sao Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Ostrava-Poruba, Plzen, Prague, Usti nad Labem
Country [22] 0 0
Denmark
State/province [22] 0 0
Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod
Country [23] 0 0
Denmark
State/province [23] 0 0
Kobenhavn, Odense
Country [24] 0 0
Finland
State/province [24] 0 0
Seinajoki
Country [25] 0 0
France
State/province [25] 0 0
Besancon, Brest, Chambray les Tours, Clamart, Grenoble
Country [26] 0 0
France
State/province [26] 0 0
Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne
Country [27] 0 0
France
State/province [27] 0 0
Toulouse, Valenciennes
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim
Country [29] 0 0
Italy
State/province [29] 0 0
Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia
Country [30] 0 0
Italy
State/province [30] 0 0
Treviso, Venezia
Country [31] 0 0
Netherlands
State/province [31] 0 0
Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem
Country [32] 0 0
Netherlands
State/province [32] 0 0
Maastricht, Nieuwegein, Sittard, Zwolle
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
Norway
State/province [34] 0 0
Oslo, Rud
Country [35] 0 0
Poland
State/province [35] 0 0
Bialystok, Szczecin, Warszawa, Wroclaw
Country [36] 0 0
South Africa
State/province [36] 0 0
Bloemfontein, Bryanston, Durban
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona, Madrid, Torrelavega, Xativa
Country [38] 0 0
Sweden
State/province [38] 0 0
Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00071279
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.
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00071279